ACUFEX 010001Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010021533), received between Aug 23, 2018 and Mar 27, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Break; Break

  IT WAS REPORTED THAT, AFTER A KNEE ARTHROSCOPY PROCEDURE, UPON FINISHING AND CLEARING THE SURGICAL TABLE, IT WAS NOTICED THAT A PART OF THE PROBE STRAIGHT WAS MISSING. THE PATIENT WAS EVALUATED WITH A C-ARM, WHICH OBTAINED A VIEW OF WHERE THE MISSING PART OF THE INSTRUMENT WAS LOCATED IN THE PATIENT'S KNEE. AN ARTHROSCOPY WAS PERFORMED ON THE SAME DAY ((B)(6) 2025) TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT. PATIENT STATUS IS GOOD.

  Patient problems: Foreign Body In Patient

  MAUDE report 21707360 ↗
• MalfunctionJan 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, THE PROBE STRAIGHT TIP BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076609 ↗
• InjurySep 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A RIGHT ANKLE ARTHROSCOPY PROCEDURE, THE ACUFEX PROBE BROKE. AN ADDITIONAL INCISION WAS NEEDED TO REMOVE THE BROKEN PIECE OF THE DEVICE. AS A RESULT, THE PATIENT WAS LEFT WITH A SCAR ON HIS ANKLE MEASURING APPROXIMATELY 4 INCHES. IT IS UNKNOWN IF THERE WAS ANY DELAY OR BACKUP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510132 ↗
• InjuryAug 17, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE PROBE BROKE AND A 1X3 MM FRAGMENT OF THE PROBE BECAME LODGED IN THE POSTERIOR RECESS IN THE POSTERIOR MEDIAL COMPARTMENT OF THE KNEE. THE PATIENT NEEDED AN EXTRA INCISION TO TRY TO RETRIEVE THE BROKEN FRAGMENT AND NUMEROUS POST-OPERATIVE X-RAYS TO DETERMINE IF THE FRAGMENT HAD MOVED. THE RETAINED FRAGMENT HAS CAUSED AND CONTINUES TO CAUSE PAIN IN THE PATIENTS KNEE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 12330646 ↗
• InjuryAug 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE STRAIGHT PROBE'S TIP BROKE OFF. IN SPITE OF TRYING TO REMOVE IT FOR ABOUT AN HOUR, IT COULDN'T BE REMOVED. THERE WAS A BACKUP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10376094 ↗
• InjuryJun 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE ACUFEX STRAIGHT PROBE BROKE. IT IS UNKNOWN HOW THE SURGERY WAS FINISHED OR IF THERE WAS A SURGICAL DELAY. 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: Foreign Body In Patient

  MAUDE report 10112701 ↗
• InjuryJun 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE ACUFEX STRAIGHT PROBE BROKE. IT IS UNKNOWN HOW THE SURGERY WAS FINISHED OR IF THERE WAS A SURGICAL DELAY. 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: Foreign Body In Patient

  MAUDE report 10112624 ↗
• MalfunctionFeb 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE ACUFEX STRAIGHT PROBE BROKE. THE TIP WAS RETRIEVED FROM THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS FINISHED. SURGERY WAS DELAYED, BUT IT IS UNKNOWN FOR HOW LONG. THE PATIENT OUTCOME IS UNKNOWN. 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 9714452 ↗
• MalfunctionOct 7, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, A STRAIGHT PROBE WAS FOUND TO BE CRACKED IN THE PATIENT ARTICULATION. THE CRACKED TIPS WERE REMOVED BY USING A PUNCH BASKET. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE IN THE SCHEDULED TIME. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9164940 ↗
• MalfunctionJan 10, 2019Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE SURGERY INSIDE THE PATIENT'S ANATOMY. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8237250 ↗
• MalfunctionAug 23, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE PROBE BROKEN DURING KNEE ARTHROSCOPY PROCEDURE. ALL PIECES WERE REMOVED. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810115 ↗