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Arthroscope

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Arthroscope

The FDA MAUDE database aggregates 24,657 adverse-event reports for Arthroscope spanning the period from 1992 through 2026. Of these, 36 are classified as death reports, 2,690 as injury reports, and 21,362 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 13 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Break topping the list at 2,099 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 2,427 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 13 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

24,657
Total Reports
36
Death Reports
2,690
Injury Reports
21,362
Malfunctions

Event Types

Malfunction 21,362 (86.6%)
Injury 2,690 (10.9%)
Other 442 (1.8%)
127 (0.5%)
Death 36 (0.1%)

Patient Outcomes

21,083 (84.7%)
Other 2,079 (8.4%)
Required Intervention 1,106 (4.4%)
Hospitalization 238 (1.0%)
R 177 (0.7%)
O 49 (0.2%)
Disability 40 (0.2%)
Life Threatening 24 (0.1%)
Death 23 (0.1%)
S 20 (0.1%)
H 19 (0.1%)
Congenital Anomaly 12 (0.0%)
L 8 (0.0%)

Top Product Problems

Break 2,099
Display or Visual Feedback Problem 1,030
Optical Problem 973
Use of Device Problem 899
Increase in Pressure 873
Electrical Shorting 656
Overheating of Device 609
Detachment of Device or Device Component 562
Material Rupture 562
Poor Quality Image 559
Electrical /Electronic Property Problem 529
Pressure Problem 459
Crack 450
Improper Flow or Infusion 433
Infusion or Flow Problem 420
Overfill 390
Output Problem 365
Leak/Splash 353
Device-Device Incompatibility 348
Scratched Material 344

Yearly Trend

92
1992: 2
93
1993: 5
94
1994: 22
95
1995: 32
96
1996: 62
97
1997: 297
98
1998: 255
99
1999: 268
00
2000: 218
01
2001: 130
02
2002: 220
03
2003: 185
04
2004: 204
05
2005: 318
06
2006: 385
07
2007: 421
08
2008: 441
09
2009: 558
10
2010: 612
11
2011: 631
12
2012: 778
13
2013: 678
14
2014: 802
15
2015: 763
16
2016: 469
17
2017: 934
18
2018: 1,581
19
2019: 1,676
20
2020: 1,706
21
2021: 1,908
22
2022: 1,406
23
2023: 1,852
24
2024: 2,427
25
2025: 2,105
26
2026: 306

Related Entities for Arthroscope

Event Locations

13,517 (54.8%)
I 7,957 (32.3%)
HOSPITAL 2,727 (11.1%)
AMBULATORY SURGICAL FACILITY 228 (0.9%)
NO INFORMATION 98 (0.4%)
INVALID DATA 38 (0.2%)
UNKNOWN 31 (0.1%)
OTHER 27 (0.1%)
OUTPATIENT TREATMENT FACILITY 21 (0.1%)
AMBULATORY SURGICAL CENTER 4 (0.0%)
HOME 4 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare DEPUY MITEK LLC US vs SMITH & NEPHEW, INC. →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.