2026 data FDA MAUDE openFDA FDA Class II

Clip, Implantable

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 II (moderate risk, special controls required), regulated under 21 CFR §878.4300 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Clip, Implantable MID-BOOK · MAUDE

#82 of 1000 · 42,204 reports · 1993–2026

  • BOOK 42,204 reports
  • RANK #82 of 1000
  • DEATH 126 death-typed
  • INJ 3,405 injury-typed
  • MALF 38,216 malfunction
  • SPAN 1993–2026
  • PEAK 2019: 2,903
  • PHOTO Neurological Stereota…

Nearest event-volume peer: Neurological Stereotaxic Instrument (522 report gap)

Clip, Implantable sits #82 of 1000 among tracked device types with 42,204 MAUDE reports spanning 1993–2026. 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

Clip, Implantable carries 90.6% MALFUNCTION-coded reports, 25.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 8.1% corpus 30.3% · below corpus mean (-22.2 pp)
  • MALF 90.6% corpus 64.8% · above corpus mean (+25.7 pp)

Lead product-problem code Failure to Form Staple is 25% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, LLC. accounts for 51% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Clip, Implantable in the event-volume neighbourhood

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

reports

What this shows Clip, Implantable carries 42,204 MAUDE reports, ranked #82 of 1000.

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

Event Types

Malfunction 38,216 (90.6%)
Injury 3,405 (8.1%)
343 (0.8%)
Death 126 (0.3%)
Other 114 (0.3%)

Patient Outcomes

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

38,177 (89.1%)
Required Intervention 2,090 (4.9%)
Other 1,219 (2.8%)
R 480 (1.1%)
Hospitalization 311 (0.7%)
Life Threatening 164 (0.4%)
Death 125 (0.3%)
O 89 (0.2%)
L 59 (0.1%)
Disability 55 (0.1%)
H 54 (0.1%)
S 34 (0.1%)
D 3 (0.0%)
Congenital Anomaly 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Failure to Form Staple 11,699
Mechanics Altered 3,928
Difficult to Open or Close 3,429
Failure to Fire 3,350
Mechanical Jam 2,696
Replace 2,682
Mechanical Problem 2,477
Misfire 2,416
Device Operates Differently Than Expected 1,955
Break 1,765
Component Falling 1,592
Positioning Failure 1,490
Sticking 1,152
Activation, Positioning or Separation Problem 982
Material Deformation 904
Unintended Ejection 786
Device Slipped 755
Detachment of Device or Device Component 702
Detachment Of Device Component 699
Failure To Adhere Or Bond 689

Yearly Trend

93
1993: 1
94
1994: 2
95
1995: 7
96
1996: 36
97
1997: 20
98
1998: 9
99
1999: 16
00
2000: 8
01
2001: 32
02
2002: 66
03
2003: 181
04
2004: 119
05
2005: 124
06
2006: 1,031
07
2007: 1,877
08
2008: 981
09
2009: 2,160
10
2010: 2,367
11
2011: 1,678
12
2012: 1,677
13
2013: 2,381
14
2014: 2,317
15
2015: 2,871
16
2016: 1,840
17
2017: 2,594
18
2018: 2,718
19
2019: 2,903
20
2020: 1,760
21
2021: 1,759
22
2022: 1,575
23
2023: 1,918
24
2024: 2,067
25
2025: 1,919
26
2026: 1,190

Reports in 2025 (1,919) held close to the prior two-year average of 1,993.

Related Entities for Clip, Implantable

Event Locations

20,784 (49.2%)
I 13,672 (32.4%)
OTHER 3,770 (8.9%)
HOSPITAL 2,208 (5.2%)
NOT APPLICABLE 1,531 (3.6%)
NO INFORMATION 191 (0.5%)
UNKNOWN 24 (0.1%)
AMBULATORY SURGICAL FACILITY 8 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (0.0%)
OPERATING ROOM 4 (0.0%)
HOME 3 (0.0%)
INVALID DATA 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ETHICON ENDO-SURGERY, LLC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Clip, Implantable: 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 (42,204 here).

Similar death-typed counts

Nearest other device types by death-typed report count (126 here), distinct from the volume row.

Disclaimer: MAUDE figures for Clip, Implantable 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 Clip, Implantable; 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.