Arthrex® AR-3355-4071Recalls & reported problems
Arthrex, Inc. · 4K C-Mount Arthroscope, 70°, 4mm x 156mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867161207), received between Jul 13, 2023 and Jul 19, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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
- Break4
- Scratched Material2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2023Scratched Material; Scratched Material
ON 06/20/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3355 4071 SCOPE HAS SCRATCHES ON THE LENS. THIS WAS DISCOVERED DURING TWO DIFFERENT PROCEDURES. THE CASE WAS COMPLETED BY USING A NEW SCOPE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17348906 ↗MalfunctionJul 19, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3355-4071 SCOPE LENS IS CRACKED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17348852 ↗MalfunctionJul 13, 2023Defective Device; Defective Device
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4071 ARTHROSCOPE WAS DAMAGED, WITH NO FURTHER DETAILS. THIS WAS DISCOVERED DURING AN ARTHROSCOPY PROCEDURE, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315741 ↗MalfunctionJul 13, 2023Scratched Material; Scratched Material
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4071 SCOPE HAS A SCRATCHED LENS. IT WAS INVOLVED IN A CASE. PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315634 ↗MalfunctionJul 13, 2023Break; Break
ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4071 SCOPE IS CRACKED. IT WAS INVOLVED IN A CASE. PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314923 ↗MalfunctionJul 13, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3355-4071 ARTHROSCOPES LENS ARE CRACKED. THIS WAS DISCOVERED DURING A CASE, THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314868 ↗MalfunctionJul 13, 2023Break; Break
ON 06/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3355-4071 ARTHROSCOPES LENS ARE CRACKED. THIS WAS DISCOVERED DURING A CASE, THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314854 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page