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2026 data FDA MAUDE openFDA FDA Class II

Endoscopic Injection Needle, Gastroenterology-Urology

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 Endoscopic Injection Needle LIGHT-BOOK · MAUDE

#851 of 1000 · 570 reports · 1994–2026

  • BOOK 570 reports
  • RANK #851 of 1000
  • DEATH 0 death-typed
  • INJ 62 injury-typed
  • MALF 500 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 94
  • PHOTO Snare, Non-Electrical

Nearest event-volume peer: Snare, Non-Electrical (2 report gap)

Endoscopic Injection Needle, Gastroenterology-Urology sits #851 of 1000 among tracked device types with 570 MAUDE reports spanning 1994–2026. 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 Injection Needle carries 87.7% MALFUNCTION-coded reports, 22.9pp 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 10.9% corpus 30.3% · below corpus mean (-19.4 pp)
  • MALF 87.7% corpus 64.8% · above corpus mean (+22.9 pp)

Lead product-problem code Failure to Deliver is 15% of coded problems · Lead manufacturer AOMORI OLYMPUS CO., LTD. accounts for 49% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Endoscopic Injection Needle in the event-volume neighbourhood

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

reports

What this shows Endoscopic Injection Needle, Gastroenterology-Urology carries 570 MAUDE reports, ranked #851 of 1000.

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

Event Types

Malfunction 500 (87.7%)
Injury 62 (10.9%)
4 (0.7%)
Other 4 (0.7%)

Patient Outcomes

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

498 (86.5%)
Required Intervention 33 (5.7%)
Other 31 (5.4%)
R 5 (0.9%)
Hospitalization 4 (0.7%)
O 3 (0.5%)
H 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Failure to Deliver 75
Break 61
No Flow 58
Adverse Event Without Identified Device or Use Problem 49
Infusion or Flow Problem 42
Mechanical Problem 29
Activation Failure 26
Failure to Infuse 26
Retraction Problem 26
Difficult to Insert 13
Obstruction of Flow 13
Detachment of Device or Device Component 12
Physical Resistance/Sticking 12
Failure to Advance 10
Material Twisted/Bent 9
Positioning Failure 9
Complete Blockage 8
Defective Device 8
Device Operates Differently Than Expected 8
Failure to Discharge 8

Yearly Trend

94
1994: 3
95
1995: 2
96
1996: 3
97
1997: 2
99
1999: 4
01
2001: 1
03
2003: 3
04
2004: 1
05
2005: 2
06
2006: 2
07
2007: 3
08
2008: 22
09
2009: 12
10
2010: 12
11
2011: 2
12
2012: 2
13
2013: 3
14
2014: 9
15
2015: 4
16
2016: 18
17
2017: 27
18
2018: 9
19
2019: 6
20
2020: 25
21
2021: 34
22
2022: 80
23
2023: 60
24
2024: 94
25
2025: 84
26
2026: 41

Reports in 2025 (84) held close to the prior two-year average of 77.

Related Entities for Endoscopic Injection Needle, Gastroenterology-Urology

Top Manufacturers

AOMORI OLYMPUS CO., LTD. 229
OLYMPUS MEDICAL SYSTEMS CORP. 154
BOSTON SCIENTIFIC CORPORATION 29
COOK ENDOSCOPY 23
WILSON-COOK MEDICAL INC 13
COLOPLAST A/S 11
AOMORI OLYMPUS CO., LTD 9

Event Locations

429 (75.3%)
I 89 (15.6%)
HOSPITAL 44 (7.7%)
NO INFORMATION 6 (1.1%)
NOT APPLICABLE 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare AOMORI OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with a comparable report-volume footprint

Endoscopic Injection Needle carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (570 here).

Snare, Non-Electrical 572 Lead, Atomic Absorption 575 Pessary, Vaginal 575 Injector, Contrast Medium, Automatic 576

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Endoscopic Injection Needle 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 Injection Needle; 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.