PlainHospital
2026 data FDA MAUDE openFDA

Passer

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.

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FDA MAUDE casebook

openFDA event book Passer LIGHT-BOOK · MAUDE

#682 of 1000 · 885 reports · 1995–2026

  • BOOK 885 reports
  • RANK #682 of 1000
  • DEATH 0 death-typed
  • INJ 189 injury-typed
  • MALF 687 malfunction
  • SPAN 1995–2026
  • PEAK 2020: 171
  • PHOTO Catheter Care Tray

Nearest event-volume peer: Catheter Care Tray (4 report gap)

Passer sits #682 of 1000 among tracked device types with 885 MAUDE reports spanning 1995–2026. 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 21.4% corpus 30.4% · below corpus mean (-9.1 pp)
  • MALF 77.6% corpus 64.5% · above corpus mean (+13.1 pp)

Lead product-problem code Break is 54% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 36% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Passer in the event-volume neighbourhood

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

reports

What this shows Passer carries 885 MAUDE reports, ranked #682 of 1000.

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

Event Types

Malfunction 687 (77.6%)
Injury 189 (21.4%)
Other 8 (0.9%)
1 (0.1%)

Patient Outcomes

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

646 (71.1%)
Required Intervention 141 (15.5%)
Other 87 (9.6%)
R 17 (1.9%)
Hospitalization 7 (0.8%)
O 5 (0.6%)
H 2 (0.2%)
L 1 (0.1%)
S 1 (0.1%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 416
Detachment of Device or Device Component 64
Material Separation 54
Mechanical Jam 36
Mechanical Problem 21
Material Fragmentation 20
Failure to Advance 19
Fracture 18
Adverse Event Without Identified Device or Use Problem 14
Material Integrity Problem 14
Device Operates Differently Than Expected 13
Material Deformation 13
Physical Resistance/Sticking 13
Detachment Of Device Component 12
Difficult to Open or Close 9
Insufficient Information 9
Device Damaged Prior to Use 7
Device Dislodged or Dislocated 6
Firing Problem 6
Bent 5

Yearly Trend

95
1995: 1
96
1996: 1
97
1997: 3
98
1998: 4
99
1999: 1
00
2000: 2
01
2001: 3
02
2002: 1
03
2003: 1
04
2004: 4
05
2005: 2
06
2006: 10
07
2007: 7
08
2008: 7
09
2009: 3
10
2010: 2
11
2011: 30
12
2012: 9
13
2013: 9
14
2014: 10
15
2015: 14
16
2016: 28
17
2017: 39
18
2018: 64
19
2019: 55
20
2020: 171
21
2021: 160
22
2022: 63
23
2023: 60
24
2024: 50
25
2025: 68
26
2026: 3

Related Entities for Passer

Top Manufacturers

SMITH & NEPHEW, INC. 261
ARTHROCARE CORP. 196
ARTHROCARE CORPORATION 142
STRYKER ENDOSCOPY-SAN JOSE 45
ZIMMER BIOMET, INC. 41
OBERDORF SYNTHES PRODUKTIONS GMBH 17
DEPUY MITEK 16

Event Locations

I 448 (50.6%)
365 (41.2%)
HOSPITAL 52 (5.9%)
NO INFORMATION 9 (1.0%)
AMBULATORY SURGICAL FACILITY 6 (0.7%)
OTHER 3 (0.3%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare SMITH & NEPHEW, INC. vs ARTHROCARE CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Passer, 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 (885 here).

Catheter Care Tray 881 Bronchoscope Accessory 890 Flow Cytometric Reagents And Accessories. 896 Suture 874

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 Passer 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 Passer; 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.