2026 data FDA MAUDE openFDA FDA Class I

Stapler, 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 §878.4740 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Stapler, Skin LIGHT-BOOK · MAUDE

#364 of 1000 · 3,772 reports · 2022–2026

  • BOOK 3,772 reports
  • RANK #364 of 1000
  • DEATH 0 death-typed
  • INJ 22 injury-typed
  • MALF 3,749 malfunction
  • SPAN 2022–2026
  • PEAK 2023: 1,293
  • PHOTO System

Nearest event-volume peer: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (38 report gap)

Stapler, Skin sits #364 of 1000 among tracked device types with 3,772 MAUDE reports spanning 2022–2026. 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

Stapler, Skin carries 99.4% MALFUNCTION-coded reports, 34.6pp 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 0.6% corpus 30.3% · below corpus mean (-29.7 pp)
  • MALF 99.4% corpus 64.8% · above corpus mean (+34.6 pp)

Lead product-problem code Mechanical Jam is 61% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 99% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Stapler, Skin in the event-volume neighbourhood

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

reports

What this shows Stapler, Skin carries 3,772 MAUDE reports, ranked #364 of 1000.

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

Event Types

Malfunction 3,749 (99.4%)
Injury 22 (0.6%)
1 (0.0%)

Patient Outcomes

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

3,709 (99.3%)
Required Intervention 11 (0.3%)
Other 7 (0.2%)
R 3 (0.1%)
Hospitalization 3 (0.1%)
Disability 2 (0.1%)
H 1 (0.0%)

Top Product Problems

Mechanical Jam 2,314
Device Damaged Prior to Receipt by User 273
Failure to Fire 256
Failure to Align 187
Failure to Form Staple 147
Physical Resistance/Sticking 100
Delivered as Unsterile Product 98
Tear, Rip or Hole in Device Packaging 88
Misfire 81
Mechanical Problem 44
Firing Problem 42
Difficult to Open or Close 31
Detachment of Device or Device Component 19
Manufacturing, Packaging or Shipping Problem 17
Material Integrity Problem 16
Unintended Ejection 16
Adverse Event Without Identified Device or Use Problem 14
Improper or Incorrect Procedure or Method 13
Use of Device Problem 11
Insufficient Device Problem Information 10

Yearly Trend

22
2022: 516
23
2023: 1,293
24
2024: 1,275
25
2025: 518
26
2026: 170

Reports fell to 518 in 2025, down from an average of 1,284 in the two years before.

Related Entities for Stapler, Skin

Event Locations

3,771 (100.0%)
HOSPITAL 1 (0.0%)

Compare TELEFLEX MEDICAL vs Teleflex Medical →

Nationwide devices with a comparable report-volume footprint

Stapler, Skin carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,772 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stapler, Skin 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 Stapler, Skin; 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.