Arthrex® AR-3352-5530Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867216761), received between Feb 21, 2018 and Jul 17, 2023 — classified as 1 injury, 3 malfunctions.

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

Recent adverse event reports

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

• MalfunctionJul 17, 2023Misfocusing; Misfocusing

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3352-5530 SCOPE HAS A BLURRY IMAGE AND HAS SPOTS ON THE LENS. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW SCOPE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336829 ↗
• MalfunctionFeb 7, 2022Overheating of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT DURING AN LAPAROSCOPIC PROCEDURE ON (B)(6) 2022, THE DISTAL TIP OF THE AR-3352-5530 LAPAROSCOPE BECAME HOT AND BURNED A HOLE IN THE DRAPE. THE SURGEON USED A BLUE CLOTH TO COVER THE BURNED DRAPE. THE PATIENT WAS NOT HARMED AND THE CASE WAS COMPLETED BY TURNING OFF THE SCOPE AND AFTER A FEW MINUTES THEY WERE ABLE TO COMPLETE THE CASE USING THE SAME SCOPE. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THIS CASE AND UPON ARRIVAL THE (B)(6) 2022, WAS ABLE TO COLLECT THE DEVICE(S) USED IN THE CASE OR EVALUATION. ADDITIONAL INFORMATION PROVIDED 1/24/2022: ALL PART AND SERIAL NUMBERS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471643 ↗
• MalfunctionJun 1, 2021Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY (GALLBLADDER REMOVAL), THE DISTAL END OF THE LAPAROSCOPE OUTER CASING BROKE OFF INTO THE PATIENT. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT; X-RAYS WERE DONE TO CONFIRM ALL PARTS REMOVED. THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912159 ↗
• InjuryFeb 21, 2018Temperature Problem

  THE SALES REP REPORTED THAT DURING A LAPAROSCOPIC COLON RESECTION THE STAFF NOTICED THE CAMERA HEAD BECAME UNUSUALLY WARM. AFTER THE CASE WAS COMPLETED, THE CAMERA HEAD AND SCOPE WERE PLACED ON THE STERILE DRAPES COVERING THE PATIENT. WHILE UNDRAPING THE STERILE DRAPES, THE SURGEON AND STAFF NOTICED THE CAMERA HEAD OR SCOPE BECAME WARM ENOUGH TO BURN THE PATIENT'S SKIN. THE BURN MARK RESEMBLED THE OUTLINE OF THE CAMERA HEAD YET IT IS UNKNOWN IF THE BURN WAS CAUSED BY THE 4K LAPAROSCOPE, AR-3352-5530 ((B)(4) LINE (B)(6)), OR THE 4K SYNERGY CAMERA HEAD, AR-3210-0029 ((B)(4) LINE (B)(6)). FOLLOW-UP INVESTIGATION: THE SETTINGS ON THE DEVICE WERE BRIGHTNESS - 5, ZOOM - 0, GAIN - LOW, AUTO EXPOSURE WINDOW - MEDIUM, ENHANCEMENT - 4, LIGHT SOURCE OUTPUT - MAX, LIGHT SOURCE AUTO - OFF. STAFF NOTICED MIDWAY THROUGH THE CASE THAT THE CAMERA HEAD AND LAPAROSCOPE WERE EXCESSIVELY WARM. ACCORDING TO IN ROOM STAFF THE FIRST REMARK WAS 1.5 HOURS INTO THE PROCEDURE. CASE WAS COMPLETED AS SCHEDULED. PATIENT'S BURN WAS A HEIGHTENED RED AREA, DISCOLORATION THAT RESEMBLED THE OUTLINE OF THE CAMERA'S COUPLER. THE BURN DID NOT BREAK THE PATIENT'S SKIN. HOSPITAL'S PROTOCOL WAS FOLLOWED: APPLY APPROPRIATE

  Patient problems: Burn, Thermal; Erythema

  MAUDE report 7285130 ↗