Arthrex® AR-3352-5531Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867346628), received between Jan 9, 2023 and Nov 12, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 10/28/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3352-5531 LAPAROSCOPES SEAL POPPED OFF. THIS WAS DISCOVERED AFTER A CASE. ADDITIONAL INFORMATION WAS PROVIDED ON 11/04/2025 VIA SEMS WHERE IT WAS REPORTED THAT THIS WAS DISCOVERED AT THE END OF A CASE BEFORE REPROCESSING.

  Patient problems: Insufficient Information

  MAUDE report 23534081 ↗
• MalfunctionJul 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 06/24/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06599319 THAT AN AR-3352-5531 SCOPE HAS A BLURRY LENS. CASE/PATIENT INVOLVEMENT NOT INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781227 ↗
• MalfunctionNov 16, 2023Poor Quality Image; Poor Quality Image

  ON 10/16/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE, VIA (B)(4), THAT AN AR-3352-5531 4K LAPAROSCOPE ROD LENS SEEMED TO BE LOOSE DUE TO AN INTERNAL FAILURE. IT WILL COME IN AND OUT OF FOCUS. IT WAS STATED THAT THE DEVICE WAS NOT DROPPED. THIS WAS DISCOVERED DURING AN ARTHROSCOPY PROCEDURE ON 10/16/2023, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151979 ↗
• MalfunctionJul 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 6/13/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3352-5531 SCOPE HAS NO PICTURE. IT WAS INVOLVED IN A CASE. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304831 ↗
• InjuryJan 9, 2023Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  ON 12/22/2022, 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: Burn(s); Superficial (First Degree) Burn

  MAUDE report 16120533 ↗