2023 data FDA MAUDE openFDA FDA Class II

Clip, Hemostatic

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, Hemostatic LIGHT-BOOK · MAUDE

#917 of 1000 · 468 reports · 1992–2023

  • BOOK 468 reports
  • RANK #917 of 1000
  • DEATH 3 death-typed
  • INJ 5 injury-typed
  • MALF 459 malfunction
  • SPAN 1992–2023
  • PEAK 2022: 125
  • PHOTO Laparoscope

Nearest event-volume peer: Laparoscope, General & Plastic Surgery, Reprocessed (0 report gap)

Clip, Hemostatic sits #917 of 1000 among tracked device types with 468 MAUDE reports spanning 1992–2023. 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, Hemostatic carries 98.1% MALFUNCTION-coded reports, 33.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 1.1% corpus 30.3% · below corpus mean (-29.2 pp)
  • MALF 98.1% corpus 64.8% · above corpus mean (+33.2 pp)

Lead product-problem code Activation, Positioning or Separation Problem is 63% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 74% of manufacturer-tagged reports · Top event location I is 53% of location-tagged rows .

Clip, Hemostatic in the event-volume neighbourhood

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

reports

What this shows Clip, Hemostatic carries 468 MAUDE reports, ranked #917 of 1000.

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

Event Types

Malfunction 459 (98.1%)
Injury 5 (1.1%)
Death 3 (0.6%)
Other 1 (0.2%)

Patient Outcomes

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

456 (97.4%)
Required Intervention 8 (1.7%)
Death 3 (0.6%)
Other 1 (0.2%)

Top Product Problems

Activation, Positioning or Separation Problem 357
Difficult to Open or Close 56
Break 36
Use of Device Problem 17
Device Contamination with Chemical or Other Material 16
Migration or Expulsion of Device 14
Material Deformation 10
Premature Activation 10
Detachment of Device or Device Component 8
Human-Device Interface Problem 7
Device Slipped 5
Entrapment of Device 5
Adverse Event Without Identified Device or Use Problem 4
Positioning Failure 4
Unintended Movement 4
Appropriate Device Problem Term/Code Not Available 3
Device Dislodged or Dislocated 3
Defective Device 2
Deformation Due to Compressive Stress 2
Difficult to Advance 2

Yearly Trend

92
1992: 1
98
1998: 1
08
2008: 1
09
2009: 1
14
2014: 47
15
2015: 41
17
2017: 1
18
2018: 92
19
2019: 77
20
2020: 53
21
2021: 27
22
2022: 125
23
2023: 1

Reports rose to 125 in 2022, up from an average of 40 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Clip, Hemostatic

Event Locations

I 249 (53.2%)
217 (46.4%)
HOSPITAL 1 (0.2%)
OTHER 1 (0.2%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - MARLBOROUGH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Clip, Hemostatic: 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 (468 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

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