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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Laparoscope, General & Plastic Surgery MID-BOOK · MAUDE

#43 of 1000 · 80,330 reports · 1992–2026

  • BOOK 80,330 reports
  • RANK #43 of 1000
  • DEATH 257 death-typed
  • INJ 6,774 injury-typed
  • MALF 72,162 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 6,047
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Implantable, For Incontinence (592 report gap)

Laparoscope, General & Plastic Surgery sits #43 of 1000 among tracked device types with 80,330 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 8.4% corpus 30.4% · below corpus mean (-22.0 pp)
  • MALF 89.8% corpus 64.5% · above corpus mean (+25.3 pp)

Lead product-problem code Break is 17% of coded problems · Lead manufacturer US SURGICAL PUERTO RICO accounts for 16% of manufacturer-tagged reports · Top event location is 46% 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 80,330 MAUDE reports, ranked #43 of 1000.

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

Event Types

Malfunction 72,162 (89.8%)
Injury 6,774 (8.4%)
641 (0.8%)
Other 496 (0.6%)
Death 257 (0.3%)

Patient Outcomes

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

64,257 (79.0%)
Other 11,130 (13.7%)
Required Intervention 3,784 (4.7%)
R 700 (0.9%)
Hospitalization 576 (0.7%)
Death 259 (0.3%)
O 154 (0.2%)
Life Threatening 147 (0.2%)
L 102 (0.1%)
Disability 94 (0.1%)
H 43 (0.1%)
S 30 (0.0%)
Congenital Anomaly 9 (0.0%)
D 3 (0.0%)

Top Product Problems

Break 6,158
No Display/Image 5,024
Detachment of Device or Device Component 4,504
Inflation Problem 2,605
Poor Quality Image 2,465
Material Split, Cut or Torn 1,932
Leak/Splash 1,617
Communication or Transmission Problem 1,541
Material Fragmentation 1,509
Peeled/Delaminated 1,408
Detachment Of Device Component 1,124
Packaging Problem 1,056
Adverse Event Without Identified Device or Use Problem 879
Crack 738
Loss of or Failure to Bond 720
Display or Visual Feedback Problem 654
Image Orientation Incorrect 648
Erratic or Intermittent Display 644
Mechanical Problem 547
Difficult to Insert 486

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: 1,638
08
2008: 1,319
09
2009: 1,994
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: 5,937
26
2026: 1,158

Related Entities for Laparoscope, General & Plastic Surgery

Top Manufacturers

US SURGICAL PUERTO RICO 6,728
UNITED STATES SURGICAL CORP. 6,595
AIZU OLYMPUS CO., LTD. 6,587
ETHICON ENDO-SURGERY, LLC. 6,232
ETHICON ENDO-SURGERY, INC. 4,175
DAVIS & GECK CARIBE LTD 3,726
APPLIED MEDICAL RESOURCES 3,198
OLYMPUS MEDICAL SYSTEMS CORP. 2,522
STRYKER ENDOSCOPY-SAN JOSE 1,933

Event Locations

36,834 (45.9%)
I 15,399 (19.2%)
HOSPITAL 15,250 (19.0%)
NOT APPLICABLE 10,050 (12.5%)
OTHER 2,107 (2.6%)
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 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare US SURGICAL PUERTO RICO vs UNITED STATES SURGICAL CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Laparoscope, General & Plastic Surgery, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (80,330 here).

Stimulator 79,738 Orthopedic Manual Surgical Instrument 78,848 Intraocular Lens 77,018 Analyzer, Chemistry, For Clinical Use 76,746

Similar death-typed counts

Nearest other device types by death-typed report count (257 here), distinct from the volume row.

Console 256 Mesh 256 Prosthesis 259 Tube, Tracheal 254

Read our methodology - how this data is sourced, computed, and verified.

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.