2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Endoscopic Injection Needle LIGHT-BOOK · MAUDE

#843 of 1000 · 543 reports · 1994–2026

  • BOOK 543 reports
  • RANK #843 of 1000
  • DEATH 0 death-typed
  • INJ 61 injury-typed
  • MALF 474 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 94
  • PHOTO Chair

Nearest event-volume peer: Chair, Positioning, Electric (0 report gap)

Endoscopic Injection Needle, Gastroenterology-Urology sits #843 of 1000 among tracked device types with 543 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 11.2% corpus 30.4% · below corpus mean (-19.2 pp)
  • MALF 87.3% corpus 64.5% · above corpus mean (+22.8 pp)

Lead product-problem code Failure to Deliver is 17% of coded problems · Lead manufacturer AOMORI OLYMPUS CO., LTD. accounts for 49% of manufacturer-tagged reports · Top event location is 74% 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 543 MAUDE reports, ranked #843 of 1000.

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

Event Types

Malfunction 474 (87.3%)
Injury 61 (11.2%)
4 (0.7%)
Other 4 (0.7%)

Patient Outcomes

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

475 (86.2%)
Other 31 (5.6%)
Required Intervention 31 (5.6%)
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 71
No Flow 57
Break 48
Infusion or Flow Problem 42
Adverse Event Without Identified Device or Use Problem 37
Mechanical Problem 29
Failure to Infuse 26
Activation Failure 24
Obstruction of Flow 12
Physical Resistance/Sticking 12
Defective Device 8
Failure to Discharge 8
Complete Blockage 7
Detachment of Device or Device Component 7
Difficult to Insert 7
Failure to Eject 7
Material Twisted/Bent 6
Corroded 5
Failure to Fire 5
Material Deformation 5

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: 14

Related Entities for Endoscopic Injection Needle, Gastroenterology-Urology

Event Locations

402 (74.0%)
I 89 (16.4%)
HOSPITAL 44 (8.1%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Endoscopic Injection Needle, 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 (543 here).

Similar death-typed counts

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

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.