NA 72202089Recalls & reported problems
Smith & Nephew, Inc. · DIRECT-VIEW ARTHROSCOPE AUTOCLAVABLE, 4.0 MM OUTER DIAMETER X 0 DEGREE DIRECTION OF VIEW, 115 DEGREE FIELD OF VIEW, 157 MM WORKING LENGTH, J-LOCK CANNULA CONNECTION · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010616883), received between Mar 30, 2021 and Oct 24, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, PART OF THE TIP CAME OFF FROM THE SCOPE AND FALL OFF INSIDE OF THE PATIENT. THE PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NINETY MINUTES OF DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12686879 ↗InjuryMar 30, 2021Break; Break
IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE TIP OF THE SCOPE WAS DEFORMED AND IT HAD PARTS MISSING. AFTER FIXING THE FEMUR SIDE WITH CLBTB, AN IMAGE WAS TAKEN AND IT WAS FOUND THAT A METAL PIECE WAS LEFT INTO THE PATIENT. THAT MEANS, THE BROKEN PIECE COULD NOT BE REMOVED. THEY DECIDED TO FINISH THE OPERATION WITHOUT ANY TREATMENT. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Foreign Body In Patient
MAUDE report 11590302 ↗
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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