Arthrex® AR-3355-1930Recalls & reported problems
Arthrex, Inc. · C-MOUNT AR-SCOPE,30°1.9X 58MM LGTH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867101463), received between Jul 14, 2023 and Dec 28, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Twisted/Bent1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2023Sharp Edges; Sharp Edges
ON 12/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-3355-1930 ENDOSCOPE "TIP IS SHARP" NOTICED DURING CASE, NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18409882 ↗MalfunctionJul 19, 2023Break; Break
ON 06/19/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3352-5500 SCOPE IS BLURRY AND AN AR-3355-1930 SCOPE IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17348996 ↗MalfunctionJul 14, 2023Break; Break
ON (B)(6)2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3355-1930 ARTHROSCOPE BROKE. THIS OCCURRED WHEN THE DOCTOR PUT TOO MUCH TORQUE ON THE DEVICE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17329689 ↗MalfunctionJul 14, 2023Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3355-1930 SCOPE WAS BENT. THIS WAS DISCOVERED AN ARTHROSCOPIC PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17329394 ↗
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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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