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2026 data FDA MAUDE openFDA FDA Class I

Holder, Needle, Gastroenterologic

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.4730 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Holder, Needle, Gastroenterologic LIGHT-BOOK · MAUDE

#654 of 1000 · 1,038 reports · 1992–2026

  • BOOK 1,038 reports
  • RANK #654 of 1000
  • DEATH 0 death-typed
  • INJ 274 injury-typed
  • MALF 739 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 104
  • PHOTO Cannula

Nearest event-volume peer: Cannula, Surgical, General & Plastic Surgery (1 report gap)

Holder, Needle, Gastroenterologic sits #654 of 1000 among tracked device types with 1,038 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 →

Malfunction reports run above the device-type norm

Holder, Needle, Gastroenterologic carries 71.2% MALFUNCTION-coded reports, 6.4pp 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 26.4% corpus 30.3% · below corpus mean (-3.9 pp)
  • MALF 71.2% corpus 64.8% · above corpus mean (+6.4 pp)

Lead product-problem code Detachment Of Device Component is 22% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 57% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Holder, Needle, Gastroenterologic in the event-volume neighbourhood

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

reports

What this shows Holder, Needle, Gastroenterologic carries 1,038 MAUDE reports, ranked #654 of 1000.

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

Event Types

Malfunction 739 (71.2%)
Injury 274 (26.4%)
Other 18 (1.7%)
7 (0.7%)

Patient Outcomes

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

731 (70.1%)
Other 212 (20.3%)
Required Intervention 86 (8.2%)
Hospitalization 8 (0.8%)
R 5 (0.5%)
O 1 (0.1%)

Top Product Problems

Detachment Of Device Component 250
Detachment of Device or Device Component 226
Retraction Problem 199
Break 122
Use of Device Problem 77
Misfire 56
Adverse Event Without Identified Device or Use Problem 38
Mechanical Problem 28
Needle, separation 22
Tip breakage 19
Device-Device Incompatibility 18
Device, or device fragments remain in patient 14
Other (for use when an appropriate device code cannot be identified) 13
Device Operates Differently Than Expected 12
Difficult to Remove 12
Unknown (for use when the device problem is not known) 12
Difficult to Open or Close 11
Material Separation 11
Device Or Device Fragments Location Unknown 9
Failure to Align 8

Yearly Trend

92
1992: 1
94
1994: 1
96
1996: 2
97
1997: 17
98
1998: 10
99
1999: 9
00
2000: 4
01
2001: 8
02
2002: 6
03
2003: 2
04
2004: 8
05
2005: 9
06
2006: 7
07
2007: 5
08
2008: 12
09
2009: 34
10
2010: 25
11
2011: 37
12
2012: 27
13
2013: 27
14
2014: 38
15
2015: 67
16
2016: 74
17
2017: 101
18
2018: 104
19
2019: 80
20
2020: 50
21
2021: 57
22
2022: 64
23
2023: 63
24
2024: 69
25
2025: 15
26
2026: 5

Reports fell to 15 in 2025, down from an average of 66 in the two years before.

Related Entities for Holder, Needle, Gastroenterologic

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 459
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 296
BOSTON SCIENTIFIC 22
ETHICON, INC. 13
TELEFLEX MEDICAL 10
ETHICON INC. 9

Event Locations

458 (44.1%)
I 453 (43.6%)
HOSPITAL 89 (8.6%)
NO INFORMATION 24 (2.3%)
INVALID DATA 9 (0.9%)
OTHER 5 (0.5%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - COSTA RICA (COYOL) →

Nationwide devices with a comparable report-volume footprint

Holder, Needle, Gastroenterologic 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 (1,038 here).

Cannula, Surgical, General & Plastic Surgery 1,037 Blood Establishment Computer Software And A… 1,034 Motor 1,030 Restraint, Protective 1,027

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 Holder, Needle, Gastroenterologic 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 Holder, Needle, Gastroenterologic; 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.