2026 data FDA MAUDE openFDA FDA Class I

Applier, Staple, Surgical,

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).

FDA MAUDE casebook

openFDA event book Applier, Staple, Surgical, LIGHT-BOOK · MAUDE

#842 of 1000 · 580 reports · 1992–2026

  • BOOK 580 reports
  • RANK #842 of 1000
  • DEATH 0 death-typed
  • INJ 85 injury-typed
  • MALF 494 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 119
  • PHOTO Blood/Plasma Collecti…

Nearest event-volume peer: Blood/Plasma Collection Device For Dna Testing (1 report gap)

Applier, Staple, Surgical, sits #842 of 1000 among tracked device types with 580 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, Staple, Surgical, carries 85.2% MALFUNCTION-coded reports, 20.3pp 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 14.7% corpus 30.3% · below corpus mean (-15.6 pp)
  • MALF 85.2% corpus 64.8% · above corpus mean (+20.3 pp)

Lead product-problem code Device-Device Incompatibility is 30% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 55% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Applier, Staple, Surgical, in the event-volume neighbourhood

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

reports

What this shows Applier, Staple, Surgical, carries 580 MAUDE reports, ranked #842 of 1000.

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

Event Types

Malfunction 494 (85.2%)
Injury 85 (14.7%)
1 (0.2%)

Patient Outcomes

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

493 (85.4%)
Required Intervention 41 (7.1%)
Other 39 (6.8%)
R 3 (0.5%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Device-Device Incompatibility 176
Activation, Positioning or Separation Problem 92
Positioning Failure 53
Unknown (for use when the device problem is not known) 48
Break 35
Difficult to Open or Close 31
Premature Activation 29
Material Deformation 25
Sticking 16
Mechanical Jam 14
Use of Device Problem 13
Tip breakage 12
Firing Problem 8
Detachment of Device or Device Component 7
Failure to Fire 7
Mechanical Problem 7
Detachment Of Device Component 6
Misfire 5
Separation Failure 5
Activation Problem 4

Yearly Trend

92
1992: 1
94
1994: 1
04
2004: 1
05
2005: 2
08
2008: 1
09
2009: 1
11
2011: 12
12
2012: 19
13
2013: 10
14
2014: 40
15
2015: 119
16
2016: 19
17
2017: 14
18
2018: 74
19
2019: 41
20
2020: 19
21
2021: 20
22
2022: 18
23
2023: 18
24
2024: 44
25
2025: 55
26
2026: 51

Reports rose to 55 in 2025, up from an average of 31 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Applier, Staple, Surgical,

Event Locations

314 (54.1%)
I 163 (28.1%)
HOSPITAL 101 (17.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
OTHER 1 (0.2%)

Compare DEPUY MITEK LLC US vs TELEFLEX MEDICAL →

Nationwide devices with a comparable report-volume footprint

Applier, Staple, Surgical, 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.

Disclaimer: MAUDE figures for Applier, Staple, Surgical, 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, Staple, Surgical,; 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.