2026 data FDA MAUDE openFDA FDA Class II

Endoscopic Grasping/Cutting Instrument, Non-Powered

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 Endoscopic Grasping/Cutting Instrument LIGHT-BOOK · MAUDE

#474 of 1000 · 2,211 reports · 2004–2026

  • BOOK 2,211 reports
  • RANK #474 of 1000
  • DEATH 1 death-typed
  • INJ 78 injury-typed
  • MALF 2,128 malfunction
  • SPAN 2004–2026
  • PEAK 2016: 759
  • PHOTO Forceps

Nearest event-volume peer: Forceps (6 report gap)

Endoscopic Grasping/Cutting Instrument, Non-Powered sits #474 of 1000 among tracked device types with 2,211 MAUDE reports spanning 2004–2026. 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 →

Malfunction reports run above the device-type norm

Endoscopic Grasping/Cutting Instrument carries 96.2% MALFUNCTION-coded reports, 31.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.5% corpus 30.3% · below corpus mean (-26.8 pp)
  • MALF 96.2% corpus 64.8% · above corpus mean (+31.4 pp)

Lead product-problem code Device Operates Differently Than Expected is 29% of coded problems · Lead manufacturer STRYKER ENDOSCOPY-SAN JOSE accounts for 95% of manufacturer-tagged reports · Top event location I is 91% of location-tagged rows .

Endoscopic Grasping/Cutting Instrument in the event-volume neighbourhood

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

reports

What this shows Endoscopic Grasping/Cutting Instrument, Non-Powered carries 2,211 MAUDE reports, ranked #474 of 1000.

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

Event Types

Malfunction 2,128 (96.2%)
Injury 78 (3.5%)
Other 3 (0.1%)
1 (0.0%)
Death 1 (0.0%)

Patient Outcomes

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

2,110 (94.5%)
Other 63 (2.8%)
Required Intervention 30 (1.3%)
O 9 (0.4%)
R 7 (0.3%)
Hospitalization 6 (0.3%)
H 4 (0.2%)
L 1 (0.0%)
Death 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Device Operates Differently Than Expected 674
Device Packaging Compromised 572
Break 554
Crack 183
Material Integrity Problem 78
Peeled/Delaminated 73
Difficult to Open or Close 29
Detachment of Device or Device Component 28
Mechanics Altered 18
Adverse Event Without Identified Device or Use Problem 16
Material Fragmentation 15
Material Separation 14
Mechanical Problem 11
Difficult to Remove 9
Insufficient Device Problem Information 9
Physical Property Issue 9
Arcing 8
Component Missing 8
Detachment Of Device Component 8
Device Inoperable 7

Yearly Trend

04
2004: 2
06
2006: 1
07
2007: 1
08
2008: 2
09
2009: 2
10
2010: 2
12
2012: 6
13
2013: 4
14
2014: 1
15
2015: 242
16
2016: 759
17
2017: 734
18
2018: 252
19
2019: 15
20
2020: 21
21
2021: 20
22
2022: 33
23
2023: 25
24
2024: 37
25
2025: 34
26
2026: 18

Reports in 2025 (34) held close to the prior two-year average of 31.

Related Entities for Endoscopic Grasping/Cutting Instrument, Non-Powered

Event Locations

I 2,018 (91.3%)
148 (6.7%)
HOSPITAL 35 (1.6%)
NO INFORMATION 7 (0.3%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare STRYKER ENDOSCOPY-SAN JOSE vs KARL STORZ SE & CO. KG →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscopic Grasping/Cutting Instrument: 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 (2,211 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Endoscopic Grasping/Cutting Instrument 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 Endoscopic Grasping/Cutting Instrument; 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.