N/A 72205156Recalls & reported problems
Smith & Nephew, Inc. · 4KO ARTHROSCOPE DV AC 4X4DEGREE5X160MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556736098), received between Mar 5, 2025 and Mar 5, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Detachment of Device or Device Component1
- Material Integrity Problem1
- Material Twisted/Bent1
- Optical Obstruction1
- Scratched Material1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2025Crack; Detachment of Device or Device Component; Material Integrity Problem; Material Twisted/Bent; Optical Obstruction; Scratched Material; Crack; Detachment of Device or Device Component; Material Integrity Problem; Material Twisted/Bent; Optical Obstruction; Scratched Material
IT WAS REPORTED THAT AFTER AN ARCR PROCEDURE PERFORMED ON (B)(6) 2025, IN WHICH A 4KO ARTHROSCOPE WAS INVOLVED X-RAYS REVEALED A WIRE-LIKE PIECE OF METAL INSIDE THE PATIENT'S BODY. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE METAL PIECE. LATER UPON REVISION IT WAS FOUND THAT THE TIP OF THE SCOPE WAS DAMAGED. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 21532150 ↗
Other Arthroscope devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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