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2026 data FDA MAUDE openFDA FDA Class I

Staple, Removable (Skin)

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 §878.4760 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Staple, Removable LIGHT-BOOK · MAUDE

#330 of 1000 · 4,743 reports · 1994–2026

  • BOOK 4,743 reports
  • RANK #330 of 1000
  • DEATH 2 death-typed
  • INJ 259 injury-typed
  • MALF 4,446 malfunction
  • SPAN 1994–2026
  • PEAK 2017: 657
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, Emergency, Powered (Resuscitator) (6 report gap)

Staple, Removable (Skin) sits #330 of 1000 among tracked device types with 4,743 MAUDE reports spanning 1994–2026. 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

Staple, Removable carries 93.7% MALFUNCTION-coded reports, 28.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.5% corpus 30.3% · below corpus mean (-24.8 pp)
  • MALF 93.7% corpus 64.8% · above corpus mean (+28.9 pp)

Lead product-problem code Mechanical Jam is 28% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 63% of manufacturer-tagged reports · Top event location is 39% of location-tagged rows .

Staple, Removable in the event-volume neighbourhood

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

reports

What this shows Staple, Removable (Skin) carries 4,743 MAUDE reports, ranked #330 of 1000.

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

Event Types

Malfunction 4,446 (93.7%)
Injury 259 (5.5%)
Other 19 (0.4%)
17 (0.4%)
Death 2 (0.0%)

Patient Outcomes

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

3,698 (77.6%)
Other 820 (17.2%)
Required Intervention 195 (4.1%)
R 24 (0.5%)
Hospitalization 17 (0.4%)
O 5 (0.1%)
Disability 4 (0.1%)
S 2 (0.0%)
Death 2 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Mechanical Jam 1,449
Failure to Form Staple 1,352
Replace 558
Sticking 378
Misfire 208
Mechanics Altered 175
Failure to Fire 118
Adverse Event Without Identified Device or Use Problem 117
Other (for use when an appropriate device code cannot be identified) 107
Device Operates Differently Than Expected 92
Difficult to Open or Close 90
Tear, Rip or Hole in Device Packaging 78
Entrapment of Device 77
Difficult to Remove 75
Break 72
Activation, Positioning or Separation Problem 63
Failure to Deliver 53
Positioning Failure 52
Delivered as Unsterile Product 48
Insufficient Device Problem Information 48

Yearly Trend

94
1994: 6
95
1995: 1
96
1996: 9
97
1997: 19
98
1998: 103
99
1999: 88
00
2000: 294
01
2001: 209
02
2002: 28
03
2003: 27
04
2004: 48
05
2005: 13
06
2006: 34
07
2007: 138
08
2008: 86
09
2009: 190
10
2010: 357
11
2011: 294
12
2012: 217
13
2013: 187
14
2014: 86
15
2015: 84
16
2016: 297
17
2017: 657
18
2018: 197
19
2019: 212
20
2020: 232
21
2021: 251
22
2022: 98
23
2023: 72
24
2024: 51
25
2025: 109
26
2026: 49

Reports rose to 109 in 2025, up from an average of 62 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Staple, Removable (Skin)

Top Manufacturers

TELEFLEX MEDICAL 2,715
ETHICON ENDO-SURGERY, INC. 606
ETHICON ENDO-SURGERY, LLC. 586
DAVIS & GECK CARIBE LTD 160
ETHICON ENDO-SURGERY, LLC 82
COVIDIEN 62
ETHICON ENDO-SURGERY, INC. (CINCINNATI) 53
PONCE - USS 26

Event Locations

1,867 (39.4%)
I 1,773 (37.4%)
NOT APPLICABLE 751 (15.8%)
HOSPITAL 163 (3.4%)
OTHER 129 (2.7%)
NO INFORMATION 44 (0.9%)
INVALID DATA 6 (0.1%)
UNKNOWN 4 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
HOME 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare TELEFLEX MEDICAL vs ETHICON ENDO-SURGERY, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Staple, Removable: 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 (4,743 here).

Ventilator, Emergency, Powered 4,749 Closed Antineoplastic And Hazardous Drug Re… 4,732 System, Nuclear Magnetic Resonance Imaging 4,713 Mesh 4,774

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Staple, Removable 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 Staple, Removable; 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.