ACUFEX 3312Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010115577), received between Jun 24, 2020 and Oct 10, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE HOOK PROBE BROKE WHILE IN USE FOR REMOVING A RADIOFREQUENCY FRAGMENT. THE SPECIALIST TRIED TO REMOVE THE PIECE INCREASING THE PRESSURE ON THE PUMP, BUT IT WAS NOT POSSIBLE TO KNOW ITS EXACT LOCATION AND MADE THE DECISION TO OPEN TO EXPLORE. X RAYS WERE TAKEN BUT THE TIP OF THE PROBE COULD NOT BE FOUND, SO THE SPECIALIST DECIDED TO CLOSE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH A THREE HOUR DELAY. THE PATIENT'S HEALTH IS STILL TO BE CONFIRMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17908328 ↗
• InjuryMay 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A SMALL JOINT ARTHROSCOPY, INTERNAL TO THE PATIENT, THE HOOK PROBE HAD A SHARPER CUT AT THE HOOK THAN BEFORE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY WITH A DIFFERENT SURGICAL TECHNIQUE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870918 ↗
• InjuryFeb 16, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A SMALL JOINT ARTHROSCOPY, INTERNAL TO THE PATIENT, THE HOOK PROBE HAS A SHARPER CUT AT THE HOOK THAN BEFORE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY WITH A DIFFERENT SURGICAL TECHNIQUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334446 ↗
• MalfunctionJun 24, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WRIST PROBES WERE EXTREMELY SHARP. THE PERFORMING SURGEON BELIEVES THEY ARE A LIABILITY TO THE WRIST ARTHROSCOPY PROCEDURES THEY PERFORM, AS THEY CAN CUT INTO AND DAMAGE NON-TARGETED TISSUE DURING THEIR USE. THERE WAS A DELAY GREATER THAN 30 MINUTES IN THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10190366 ↗
• MalfunctionJun 24, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE WRIST PROBE WAS EXTREMELY SHARP. THE PERFORMING SURGEON BELIEVES THEY ARE A LIABILITY TO THE WRIST ARTHROSCOPY PROCEDURES THEY PERFORM, AS THEY CAN CUT INTO AND DAMAGE NON-TARGETED TISSUE DURING THEIR USE. THERE WAS A DELAY OF MORE THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10190335 ↗