Arthrex® AR-3210-0033Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867348844), received between Feb 14, 2022 and May 10, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CONNECTION BETWEEN CAMERA AND OPTICS IS TOO LOOSE. IMAGE WOBBLES DURING THE WORK. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288531 ↗
• MalfunctionApr 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE IS OVERHEATING. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055834 ↗
• MalfunctionJan 9, 2023Temperature Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT WAS BURNED AFTER AN AR-3210-0033 CAMERA HEAD WAS PLACED ON THE PATIENT AFTER A LAPAROSCOPIC PROCEDURE ON (B)(6) 2022. THE LIGHT CORD AND SCOPE WERE DISCONNECTED, THEN THE CAMERA WAS PLACED ON THE PATIENTS SKIN, THAT RESULTED IN A BURN. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16120538 ↗
• InjuryFeb 14, 2022Overheating of Device

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0025 SYNERGY CONSOLE WAS INVOLVED IN CASE WHEN A PATIENT WAS BURNED. ADDITIONAL INFORMATION PROVIDED 12/09/2021: 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 13525205 ↗