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2026 data FDA MAUDE openFDA FDA Class II

Resectoscope, Working Element

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).

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FDA MAUDE casebook

openFDA event book Resectoscope, Working Element LIGHT-BOOK · MAUDE

#936 of 1000 · 440 reports · 1992–2026

  • BOOK 440 reports
  • RANK #936 of 1000
  • DEATH 2 death-typed
  • INJ 91 injury-typed
  • MALF 303 malfunction
  • SPAN 1992–2026
  • PEAK 1999: 32
  • PHOTO Inhibitor

Nearest event-volume peer: Inhibitor, Peridural Fibrosis (Adhesion Barrier) (0 report gap)

Resectoscope, Working Element sits #936 of 1000 among tracked device types with 440 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, Working Element carries 20.7% INJURY-coded reports, 9.6pp 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 (-1.1 pp)
  • INJ 20.7% corpus 30.3% · below corpus mean (-9.6 pp)
  • MALF 68.9% corpus 64.8% · above corpus mean (+4.0 pp)

Lead product-problem code Break is 27% of coded problems · Lead manufacturer GYRUS ACMI, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Resectoscope, Working Element in the event-volume neighbourhood

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

reports

What this shows Resectoscope, Working Element carries 440 MAUDE reports, ranked #936 of 1000.

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

Event Types

Malfunction 303 (68.9%)
Injury 91 (20.7%)
Other 37 (8.4%)
7 (1.6%)
Death 2 (0.5%)

Patient Outcomes

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

294 (65.3%)
Other 95 (21.1%)
Required Intervention 33 (7.3%)
Hospitalization 14 (3.1%)
R 5 (1.1%)
O 4 (0.9%)
S 2 (0.4%)
Death 2 (0.4%)
Disability 1 (0.2%)

Top Product Problems

Break 111
Sparking 37
Detachment Of Device Component 35
Tip breakage 30
Replace 23
Smoking 20
Thermal Decomposition of Device 20
Material Fragmentation 18
Device, removal of (non-implant) 14
Arcing 13
Other (for use when an appropriate device code cannot be identified) 13
Wire(s), breakage of 13
Unknown (for use when the device problem is not known) 10
Noise 9
Shock, electrical 9
Component Falling 8
Component(s), broken 8
Difficult to Remove 8
Fracture 8
Material Separation 8

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 6
95
1995: 7
96
1996: 12
97
1997: 18
98
1998: 16
99
1999: 32
00
2000: 16
01
2001: 15
02
2002: 8
03
2003: 9
04
2004: 14
05
2005: 8
06
2006: 5
07
2007: 15
08
2008: 19
09
2009: 13
10
2010: 10
11
2011: 16
12
2012: 27
13
2013: 21
14
2014: 29
15
2015: 12
16
2016: 1
17
2017: 9
18
2018: 4
19
2019: 14
20
2020: 10
21
2021: 5
22
2022: 5
23
2023: 9
24
2024: 11
25
2025: 21
26
2026: 19

Reports rose to 21 in 2025, up from an average of 10 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Resectoscope, Working Element

Top Manufacturers

GYRUS ACMI, INC. 44
OLYMPUS WINTER & IBE GMBH 34
KARL STORZ SE & CO. KG 28

Event Locations

210 (47.7%)
HOSPITAL 167 (38.0%)
I 35 (8.0%)
INVALID DATA 10 (2.3%)
AMBULATORY SURGICAL FACILITY 7 (1.6%)
NO INFORMATION 4 (0.9%)
OTHER 3 (0.7%)
NOT APPLICABLE 2 (0.5%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare GYRUS ACMI, INC. vs OLYMPUS WINTER & IBE GMBH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Resectoscope, Working Element: 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 (440 here).

Inhibitor, Peridural Fibrosis 440 Biliary Catheter For Stone Removal That May… 441 Lithotriptor, Electro-Hydraulic 438 Stimulator 438

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Resectoscope, Working Element 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, Working Element; 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.