2026 data FDA MAUDE openFDA FDA Class II

Laparoscope, General & Plastic Surgery, Reprocessed

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 §876.1500 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Laparoscope LIGHT-BOOK · MAUDE

#918 of 1000 · 468 reports · 2006–2026

  • BOOK 468 reports
  • RANK #918 of 1000
  • DEATH 1 death-typed
  • INJ 47 injury-typed
  • MALF 418 malfunction
  • SPAN 2006–2026
  • PEAK 2013: 102
  • PHOTO Clip, Hemostatic

Nearest event-volume peer: Clip, Hemostatic (0 report gap)

Laparoscope, General & Plastic Surgery, Reprocessed sits #918 of 1000 among tracked device types with 468 MAUDE reports spanning 2006–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Laparoscope carries 89.3% MALFUNCTION-coded reports, 24.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 10.0% corpus 30.3% · below corpus mean (-20.3 pp)
  • MALF 89.3% corpus 64.8% · above corpus mean (+24.5 pp)

Lead product-problem code Leak/Splash is 34% of coded problems · Top event location is 76% of location-tagged rows .

Laparoscope in the event-volume neighbourhood

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

reports

What this shows Laparoscope, General & Plastic Surgery, Reprocessed carries 468 MAUDE reports, ranked #918 of 1000.

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

Event Types

Malfunction 418 (89.3%)
Injury 47 (10.0%)
2 (0.4%)
Death 1 (0.2%)

Patient Outcomes

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

408 (85.2%)
Required Intervention 33 (6.9%)
Other 18 (3.8%)
R 6 (1.3%)
Hospitalization 4 (0.8%)
L 3 (0.6%)
H 2 (0.4%)
Disability 2 (0.4%)
O 1 (0.2%)
Death 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Leak/Splash 166
Break 150
Fracture 27
Device Contamination with Chemical or Other Material 24
Detachment Of Device Component 17
Device Operates Differently Than Expected 11
Detachment of Device or Device Component 9
Material Fragmentation 8
Material Integrity Problem 8
Material Separation 8
Use of Device Problem 8
Gas/Air Leak 7
Insufficient Device Problem Information 7
Device Or Device Fragments Location Unknown 6
Device Packaging Compromised 6
Retraction Problem 5
Component Falling 4
Component Missing 4
Device Slipped 4
Out-Of-Box Failure 4

Yearly Trend

06
2006: 6
07
2007: 2
08
2008: 1
09
2009: 2
10
2010: 11
11
2011: 7
12
2012: 82
13
2013: 102
14
2014: 84
15
2015: 27
16
2016: 39
17
2017: 15
18
2018: 9
19
2019: 6
20
2020: 1
21
2021: 5
22
2022: 5
23
2023: 5
24
2024: 4
25
2025: 11
26
2026: 44

Reports rose to 11 in 2025, up from an average of 5 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Laparoscope, General & Plastic Surgery, Reprocessed

Event Locations

358 (76.5%)
I 68 (14.5%)
HOSPITAL 34 (7.3%)
NO INFORMATION 4 (0.9%)
OTHER 3 (0.6%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Laparoscope: 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 (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Laparoscope 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 Laparoscope; 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.