2026 data FDA MAUDE openFDA FDA Class II

Laparoscope, General & Plastic Surgery

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, General & Plastic Surgery MID-BOOK · MAUDE

#44 of 1000 · 83,414 reports · 1992–2026

  • BOOK 83,414 reports
  • RANK #44 of 1000
  • DEATH 262 death-typed
  • INJ 6,932 injury-typed
  • MALF 75,082 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 6,047
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Implantable, For Incontinence (859 report gap)

Laparoscope, General & Plastic Surgery sits #44 of 1000 among tracked device types with 83,414 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

Laparoscope, General & Plastic Surgery carries 90.0% MALFUNCTION-coded reports, 25.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 8.3% corpus 30.3% · below corpus mean (-22.0 pp)
  • MALF 90.0% corpus 64.8% · above corpus mean (+25.2 pp)

Lead product-problem code Break is 15% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 17% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Laparoscope, General & Plastic Surgery 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 carries 83,414 MAUDE reports, ranked #44 of 1000.

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

Event Types

Malfunction 75,082 (90.0%)
Injury 6,932 (8.3%)
641 (0.8%)
Other 497 (0.6%)
Death 262 (0.3%)

Patient Outcomes

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

66,327 (79.4%)
Other 11,211 (13.4%)
Required Intervention 3,843 (4.6%)
R 708 (0.8%)
Hospitalization 581 (0.7%)
Death 264 (0.3%)
O 159 (0.2%)
Life Threatening 147 (0.2%)
L 102 (0.1%)
Disability 94 (0.1%)
H 46 (0.1%)
S 30 (0.0%)
Congenital Anomaly 9 (0.0%)
D 3 (0.0%)

Top Product Problems

Break 11,256
Replace 10,356
Device Issue 5,988
No Display/Image 5,419
Detachment of Device or Device Component 5,028
Detachment Of Device Component 4,474
Inflation Problem 3,584
Leak/Splash 3,311
Poor Quality Image 2,920
Tears, rips, holes in device, device material 2,824
Failure to Form Staple 2,788
Sticking 2,501
Component(s), broken 2,121
Material Split, Cut or Torn 2,075
Material Fragmentation 1,990
Air Leak 1,860
Communication or Transmission Problem 1,710
Peeled/Delaminated 1,562
Failure to Fire 1,558
Gas/Air Leak 1,411

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 17
95
1995: 72
96
1996: 1,315
97
1997: 4,267
98
1998: 4,450
99
1999: 3,696
00
2000: 2,996
01
2001: 1,433
02
2002: 921
03
2003: 1,040
04
2004: 1,360
05
2005: 1,479
06
2006: 1,203
07
2007: 1,639
08
2008: 1,319
09
2009: 1,995
10
2010: 2,657
11
2011: 2,133
12
2012: 1,526
13
2013: 1,564
14
2014: 1,711
15
2015: 1,710
16
2016: 2,080
17
2017: 3,467
18
2018: 2,562
19
2019: 2,578
20
2020: 2,618
21
2021: 3,431
22
2022: 3,945
23
2023: 6,002
24
2024: 6,047
25
2025: 5,936
26
2026: 4,241

Reports in 2025 (5,936) held close to the prior two-year average of 6,025.

Related Entities for Laparoscope, General & Plastic Surgery

Event Locations

39,862 (47.8%)
I 15,398 (18.5%)
HOSPITAL 15,306 (18.3%)
NOT APPLICABLE 10,050 (12.0%)
OTHER 2,107 (2.5%)
NO INFORMATION 408 (0.5%)
INVALID DATA 120 (0.1%)
UNKNOWN 86 (0.1%)
AMBULATORY SURGICAL FACILITY 54 (0.1%)
OUTPATIENT TREATMENT FACILITY 10 (0.0%)
HOME 7 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare AIZU OLYMPUS CO., LTD. vs US SURGICAL PUERTO RICO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Laparoscope, General & Plastic Surgery: 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 (83,414 here).

Similar death-typed counts

Nearest other device types by death-typed report count (262 here), distinct from the volume row.

Disclaimer: MAUDE figures for Laparoscope, General & Plastic Surgery 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, General & Plastic Surgery; 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.