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2026 data FDA MAUDE openFDA

Laparoscope, Gynecologic (And Accessories)

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, Gynecologic MID-BOOK · MAUDE

#171 of 1000 · 14,581 reports · 1993–2026

  • BOOK 14,581 reports
  • RANK #171 of 1000
  • DEATH 24 death-typed
  • INJ 636 injury-typed
  • MALF 13,830 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 4,570
  • PHOTO Dressing

Nearest event-volume peer: Dressing, Wound, Occlusive (2 report gap)

Laparoscope, Gynecologic (And Accessories) sits #171 of 1000 among tracked device types with 14,581 MAUDE reports spanning 1993–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 4.4% corpus 30.4% · below corpus mean (-26.1 pp)
  • MALF 94.8% corpus 64.5% · above corpus mean (+30.3 pp)

Lead product-problem code Poor Quality Image is 36% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 70% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Laparoscope, Gynecologic in the event-volume neighbourhood

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

reports

What this shows Laparoscope, Gynecologic (And Accessories) carries 14,581 MAUDE reports, ranked #171 of 1000.

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

Event Types

Malfunction 13,830 (94.8%)
Injury 636 (4.4%)
Other 65 (0.4%)
26 (0.2%)
Death 24 (0.2%)

Patient Outcomes

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

13,641 (93.2%)
Required Intervention 415 (2.8%)
Other 241 (1.6%)
R 110 (0.8%)
Death 88 (0.6%)
Hospitalization 52 (0.4%)
L 21 (0.1%)
Life Threatening 18 (0.1%)
S 17 (0.1%)
O 13 (0.1%)
H 7 (0.0%)
Disability 7 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Poor Quality Image 3,996
No Display/Image 1,151
Break 1,014
Communication or Transmission Problem 878
Dent in Material 489
Erratic or Intermittent Display 417
Optical Discoloration 404
Material Split, Cut or Torn 302
Output Problem 286
Crack 252
Scratched Material 240
Fracture 236
Leak/Splash 224
Image Display Error/Artifact 210
Failure to Cut 200
Optical Problem 199
Loose or Intermittent Connection 186
Display or Visual Feedback Problem 173
Material Twisted/Bent 163
Appropriate Term/Code Not Available 154

Yearly Trend

93
1993: 2
94
1994: 9
95
1995: 1
96
1996: 8
97
1997: 3
98
1998: 7
99
1999: 16
00
2000: 39
01
2001: 22
02
2002: 13
03
2003: 11
04
2004: 19
05
2005: 21
06
2006: 33
07
2007: 181
08
2008: 359
09
2009: 403
10
2010: 214
11
2011: 417
12
2012: 1,118
13
2013: 1,035
14
2014: 175
15
2015: 124
16
2016: 205
17
2017: 89
18
2018: 53
19
2019: 44
20
2020: 49
21
2021: 132
22
2022: 216
23
2023: 824
24
2024: 3,496
25
2025: 4,570
26
2026: 673

Related Entities for Laparoscope, Gynecologic (And Accessories)

Top Manufacturers

OLYMPUS WINTER & IBE GMBH 9,566
ETHICON, INC. 2,705
ETHICON INC. 886
APPLIED MEDICAL RESOURCES 374
ETHICON, INC 92
ETHICON ENDO-SURGERY, INC. 39

Event Locations

10,632 (72.9%)
HOSPITAL 3,221 (22.1%)
I 573 (3.9%)
NOT APPLICABLE 61 (0.4%)
OTHER 46 (0.3%)
NO INFORMATION 23 (0.2%)
INVALID DATA 8 (0.1%)
AMBULATORY SURGICAL CENTER 4 (0.0%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
UNKNOWN 4 (0.0%)
HOSPICE 3 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare OLYMPUS WINTER & IBE GMBH vs ETHICON, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Laparoscope, Gynecologic, 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 (14,581 here).

Dressing, Wound, Occlusive 14,583 Tube Tracheostomy And Tube Cuff 14,497 Pump, Infusion, Enteral 14,791 Suture, Surgical, Absorbable, Polydioxanone 14,884

Similar death-typed counts

Nearest other device types by death-typed report count (24 here), distinct from the volume row.

Apparatus, Suction, Patient Care 24 Catheter, Oximeter, Fiber-Optic 24 Chair, Positioning, Electric 24 Mesh 24

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

Disclaimer: MAUDE figures for Laparoscope, Gynecologic 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, Gynecologic; 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.