ECTRA 4101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010121585), received between Mar 21, 2022 and Nov 5, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ENDOSCOPIC CARPAL TUNNEL RELEASE, THE SURGEON WAS USING ONE (1) DISSECTOR BLUNT CURVED ECTR TO CLEAR THE SOFT TISSUE IN THE WRIST IN ORDER TO INSERT THE SCOPE INTO THE PATIENT'S ANATOMY TO COMPLETE THE SURGERY. WHEN INSERTED THE TIP OF THE DISSECTOR, IT SNAPPED OFF AND REMAINED IN SITU. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO AN OPEN PROCEDURE TO COMPLETE THE CARPAL TUNNEL RELEASE AND RETRIEVE THE PIECE OF THE DISSECTOR FROM THE PATIENT WITH SUCTION AND USING A SURGICAL FORCEPS. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION, AND ADDITIONAL AND LENGTHENED SURGICAL INCISIONS WERE REQUIRED DUE TO THIS ISSUE. THE PATIENT IS RECOVERING AS EXPECTED FOR A POSTOPERATIVE COURSE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477773 ↗
• InjurySep 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A WRIST PROCEDURE, THE BLUNT DISSECTOR DEVICE BROKE AT THE DISTAL END OF THE CARPAL TUNNEL; REQUIRING A 20 MINUTE REMOVAL PROCEDURE USING C-ARM IMAGING AND EXTENSIVE EXTENSION OF THE DISTAL INCISION TO FIND AND REMOVE THE TIP. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808069 ↗
• InjuryMar 21, 2022Break; Break

  IT WAS REPORTED THAT DURING A WRIST TUNNEL CARPAL SURGERY, THE 'BLUNT DISSECTOR' IN THE LOAN SET BROKE OFF WITHOUT ANY PRESSURE BEING ON THE INSTRUMENT, THE DEVICE WAS OLD AND WORN. THE BROKEN PIECE WAS LEFT IN THE PATIENT, BUT IT WAS SUCCESSFULLY RETRIEVED BY REVERTING TO OPEN SURGERY, THEN ALL THE PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAYS AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841309 ↗