Arthrex® AR-3352-5545Recalls & reported problems
Arthrex, Inc. · 4K LAPAROSCOPE, 45°, 5.5x302MM, HI-MAG · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867216778), received between Feb 14, 2022 and Feb 14, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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
- Output Problem1
Patient problems
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2022Output Problem
ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN (B)(4) SYNERGY CONSOLE WAS INVOLVED IN CASE WHEN A PATIENT WAS BURNED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2021: THE CASE WAS FINISHED AS PLANNED WITH NO KNOWN INCIDENT. APPROXIMATELY 15 MINUTES POST OP, IT WAS BROUGHT TO OUR ATTENTION VIA THE SURGICAL TECH IN THE ROOM THAT THE PATIENT HAD SUSTAINED A BURN INJURY AND THEY BELIEVED IT TO BE DUE TO THE HEAT LEVEL OF OUR LIGHT CORD / LIGHT POST CONNECTION.
Patient problems: Superficial (First Degree) Burn
MAUDE report 13525240 ↗
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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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