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2026 data FDA MAUDE openFDA

Hysteroscope (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 Hysteroscope LIGHT-BOOK · MAUDE

#245 of 1000 · 7,561 reports · 1992–2026

  • BOOK 7,561 reports
  • RANK #245 of 1000
  • DEATH 41 death-typed
  • INJ 1,549 injury-typed
  • MALF 5,918 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,719
  • PHOTO Glucose Oxidase

Nearest event-volume peer: Glucose Oxidase, Glucose (17 report gap)

Hysteroscope (And Accessories) sits #245 of 1000 among tracked device types with 7,561 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 20.5% corpus 30.4% · below corpus mean (-10.0 pp)
  • MALF 78.3% corpus 64.5% · above corpus mean (+13.8 pp)

Lead product-problem code Break is 53% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 70% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Hysteroscope in the event-volume neighbourhood

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

reports

What this shows Hysteroscope (And Accessories) carries 7,561 MAUDE reports, ranked #245 of 1000.

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

Event Types

Malfunction 5,918 (78.3%)
Injury 1,549 (20.5%)
Death 41 (0.5%)
Other 39 (0.5%)
14 (0.2%)

Patient Outcomes

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

5,824 (73.2%)
Other 758 (9.5%)
Required Intervention 651 (8.2%)
Hospitalization 242 (3.0%)
R 235 (3.0%)
O 125 (1.6%)
H 56 (0.7%)
Death 41 (0.5%)
L 10 (0.1%)
S 7 (0.1%)
Life Threatening 5 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Break 3,454
Detachment of Device or Device Component 855
Adverse Event Without Identified Device or Use Problem 608
Crack 205
Material Fragmentation 200
Loose or Intermittent Connection 124
Mechanical Problem 116
Material Separation 115
Component Missing 88
Insufficient Information 88
Material Integrity Problem 85
Fracture 82
Poor Quality Image 74
Material Protrusion/Extrusion 70
Material Deformation 68
Mechanical Jam 53
Use of Device Problem 52
Material Opacification 45
Appropriate Term/Code Not Available 42
Device Operates Differently Than Expected 39

Yearly Trend

92
1992: 2
93
1993: 4
94
1994: 1
95
1995: 2
96
1996: 8
97
1997: 12
98
1998: 13
99
1999: 9
00
2000: 4
01
2001: 11
02
2002: 8
03
2003: 6
04
2004: 15
05
2005: 26
06
2006: 12
07
2007: 7
08
2008: 12
09
2009: 17
10
2010: 31
11
2011: 59
12
2012: 78
13
2013: 111
14
2014: 125
15
2015: 211
16
2016: 172
17
2017: 336
18
2018: 182
19
2019: 220
20
2020: 253
21
2021: 193
22
2022: 289
23
2023: 1,449
24
2024: 1,611
25
2025: 1,719
26
2026: 353

Related Entities for Hysteroscope (And Accessories)

Top Manufacturers

OLYMPUS WINTER & IBE GMBH 4,147
KARL STORZ SE & CO. KG 439
HOLOGIC, INC 371
HOLOGIC, INC. 314
SMITH & NEPHEW, INC. 170
ETHICON INC. 162
SHIRAKAWA OLYMPUS CO., LTD. 159
GYRUS ACMI, INC. 142

Event Locations

5,665 (74.9%)
I 1,291 (17.1%)
HOSPITAL 528 (7.0%)
NO INFORMATION 31 (0.4%)
AMBULATORY SURGICAL FACILITY 21 (0.3%)
INVALID DATA 8 (0.1%)
OUTPATIENT TREATMENT FACILITY 6 (0.1%)
OTHER 4 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
UNKNOWN 2 (0.0%)
HOME 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare OLYMPUS WINTER & IBE GMBH vs KARL STORZ SE & CO. KG →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Hysteroscope, 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 (7,561 here).

Glucose Oxidase, Glucose 7,578 Catheter, Embolectomy 7,486 Defibrillator, Implantable, Dual-Chamber 7,651 Intracranial Neurovascular Stent 7,431

Similar death-typed counts

Nearest other device types by death-typed report count (41 here), distinct from the volume row.

Bed, Flotation Therapy, Powered 41 Filter, Bacterial, Breathing-Circuit 41 Source, Brachytherapy, Radionuclide 41 Suture, Surgical, Absorbable, Polydioxanone 41

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

Disclaimer: MAUDE figures for Hysteroscope 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 Hysteroscope; 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.