2026 data FDA MAUDE openFDA FDA Class II

Resectoscope

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 Resectoscope LIGHT-BOOK · MAUDE

#682 of 1000 · 940 reports · 1992–2026

  • BOOK 940 reports
  • RANK #682 of 1000
  • DEATH 5 death-typed
  • INJ 244 injury-typed
  • MALF 630 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 74
  • PHOTO Catheter Care Tray

Nearest event-volume peer: Catheter Care Tray (4 report gap)

Resectoscope sits #682 of 1000 among tracked device types with 940 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 →

Injury-coded reports sit below the device-type norm

Resectoscope carries 26.0% INJURY-coded reports, 4.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 26.0% corpus 30.3% · below corpus mean (-4.3 pp)
  • MALF 67.0% corpus 64.8% · above corpus mean (+2.2 pp)

Lead product-problem code Break is 34% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 77% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Resectoscope in the event-volume neighbourhood

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

reports

What this shows Resectoscope carries 940 MAUDE reports, ranked #682 of 1000.

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

Event Types

Malfunction 630 (67.0%)
Injury 244 (26.0%)
Other 40 (4.3%)
21 (2.2%)
Death 5 (0.5%)

Patient Outcomes

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

602 (61.5%)
Other 151 (15.4%)
Required Intervention 142 (14.5%)
R 24 (2.5%)
Hospitalization 24 (2.5%)
Disability 10 (1.0%)
O 8 (0.8%)
H 5 (0.5%)
Life Threatening 5 (0.5%)
Death 3 (0.3%)
S 2 (0.2%)
Invalid Data 2 (0.2%)
L 1 (0.1%)

Top Product Problems

Break 520
Material Fragmentation 247
Fracture 202
Mechanical Problem 191
Detachment Of Device Component 67
Detachment of Device or Device Component 54
Tip breakage 52
Component Falling 31
Material Separation 24
Component(s), broken 20
Insufficient Device Problem Information 18
Replace 18
Sparking 18
Arcing 15
Thermal Decomposition of Device 15
Crack 13
Unknown (for use when the device problem is not known) 10
Difficult to Remove 9
Smoking 9
Adverse Event Without Identified Device or Use Problem 8

Yearly Trend

92
1992: 3
93
1993: 4
94
1994: 8
95
1995: 8
96
1996: 19
97
1997: 23
98
1998: 17
99
1999: 19
00
2000: 17
01
2001: 10
02
2002: 2
03
2003: 16
04
2004: 12
05
2005: 12
06
2006: 11
07
2007: 11
08
2008: 11
09
2009: 15
10
2010: 34
11
2011: 18
12
2012: 26
13
2013: 24
14
2014: 36
15
2015: 45
16
2016: 25
17
2017: 28
18
2018: 50
19
2019: 53
20
2020: 55
21
2021: 54
22
2022: 74
23
2023: 74
24
2024: 34
25
2025: 68
26
2026: 24

Reports in 2025 (68) held close to the prior two-year average of 54.

Related Entities for Resectoscope

Event Locations

406 (43.2%)
HOSPITAL 257 (27.3%)
I 198 (21.1%)
NO INFORMATION 39 (4.1%)
AMBULATORY SURGICAL FACILITY 12 (1.3%)
INVALID DATA 11 (1.2%)
OUTPATIENT TREATMENT FACILITY 6 (0.6%)
OTHER 4 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.3%)
UNKNOWN 3 (0.3%)
NOT APPLICABLE 1 (0.1%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Resectoscope: 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 (940 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Disclaimer: MAUDE figures for Resectoscope 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 Resectoscope; 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.