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2026 data FDA MAUDE openFDA FDA Class I

Applier, Surgical, Clip

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Applier, Surgical, Clip MID-BOOK · MAUDE

#164 of 1000 · 16,547 reports · 1992–2026

  • BOOK 16,547 reports
  • RANK #164 of 1000
  • DEATH 40 death-typed
  • INJ 1,083 injury-typed
  • MALF 15,142 malfunction
  • SPAN 1992–2026
  • PEAK 1999: 1,692
  • PHOTO Dc-Defibrillator

Nearest event-volume peer: Dc-Defibrillator, Low-Energy, (Including Paddles) (32 report gap)

Applier, Surgical, Clip sits #164 of 1000 among tracked device types with 16,547 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Applier, Surgical, Clip carries 91.5% MALFUNCTION-coded reports, 26.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 6.5% corpus 30.3% · below corpus mean (-23.7 pp)
  • MALF 91.5% corpus 64.8% · above corpus mean (+26.7 pp)

Lead product-problem code Replace is 25% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, INC. accounts for 30% of manufacturer-tagged reports · Top event location NOT APPLICABLE is 47% of location-tagged rows .

Applier, Surgical, Clip in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Applier, Surgical, Clip carries 16,547 MAUDE reports, ranked #164 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 15,142 (91.5%)
Injury 1,083 (6.5%)
Other 153 (0.9%)
129 (0.8%)
Death 40 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

8,606 (51.3%)
Other 6,970 (41.5%)
Required Intervention 739 (4.4%)
R 154 (0.9%)
Hospitalization 120 (0.7%)
Disability 45 (0.3%)
Death 39 (0.2%)
Life Threatening 34 (0.2%)
O 22 (0.1%)
S 15 (0.1%)
L 12 (0.1%)
H 8 (0.0%)
Invalid Data 6 (0.0%)
D 3 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Replace 5,151
Failure to Form Staple 4,431
Misfire 1,561
Clips, scissored 1,237
Sticking 1,010
Break 815
Failure to Fire 775
Failure to Deliver 708
Failure to Align 618
Device Issue 513
Mechanics Altered 505
Device Operates Differently Than Expected 495
Failure to Advance 490
Detachment Of Device Component 380
Difficult to Open or Close 374
Component Falling 366
Close, difficult to 320
Material Deformation 269
Mechanical Jam 239
Malfunction 235

Yearly Trend

92
1992: 5
93
1993: 13
94
1994: 25
95
1995: 22
96
1996: 359
97
1997: 871
98
1998: 901
99
1999: 1,692
00
2000: 1,443
01
2001: 793
02
2002: 401
03
2003: 526
04
2004: 989
05
2005: 870
06
2006: 637
07
2007: 523
08
2008: 425
09
2009: 547
10
2010: 447
11
2011: 170
12
2012: 179
13
2013: 232
14
2014: 307
15
2015: 184
16
2016: 440
17
2017: 315
18
2018: 368
19
2019: 293
20
2020: 221
21
2021: 304
22
2022: 361
23
2023: 365
24
2024: 287
25
2025: 548
26
2026: 484

Reports rose to 548 in 2025, up from an average of 326 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Applier, Surgical, Clip

Top Manufacturers

ETHICON ENDO-SURGERY, INC. 2,967
ETHICON ENDO-SURGERY, LLC. 2,709
TELEFLEX MEDICAL 1,817
ETHICON ENDO-SURGERY, INC. (CINCINNATI) 1,123
ETHICON ENDO SURGERY, INC. (CINCINNATI) 729
DAVIS & GECK CARIBE LTD 330
ETHICON ENDO-SURGERY, LLC 282

Event Locations

NOT APPLICABLE 7,824 (47.3%)
4,156 (25.1%)
I 1,823 (11.0%)
HOSPITAL 1,640 (9.9%)
OTHER 978 (5.9%)
NO INFORMATION 49 (0.3%)
INVALID DATA 45 (0.3%)
AMBULATORY SURGICAL FACILITY 11 (0.1%)
UNKNOWN 11 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
HOME 3 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare ETHICON ENDO-SURGERY, INC. vs ETHICON ENDO-SURGERY, LLC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Applier, Surgical, Clip: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (16,547 here).

Dc-Defibrillator, Low-Energy, 16,579 Prosthesis 16,505 Cardiac Ablation Percutaneous Catheter 16,442 Prosthesis 16,332

Similar death-typed counts

Nearest other device types by death-typed report count (40 here), distinct from the volume row.

Appliance, Fixation, Spinal Interlaminal 40 Pacemaker Lead Adaptor 40 Prosthesis, Hip, Femoral, Resurfacing 40 Walker, Mechanical 40

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Applier, Surgical, Clip are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Applier, Surgical, Clip; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.