NA MIC81010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888551001953), received between Apr 22, 2019 and Jul 5, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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 5, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH TWO REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE BLADES WERE REPORTED TO BE DULL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14920328 ↗
• MalfunctionJul 5, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH TWO REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE BLADES WERE REPORTED TO BE DULL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14920258 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE ENDOSCOPIC BLADE BROKE INSIDE THE PATIENT. THERE WAS NO DIFFICULTY, PROCEDURAL OR PATIENT CIRCUMSTANCE IDENTIFIED BEFORE THE BREAK THAT CONTRIBUTED TO THE ISSUE REPORTED. THE FRAGMENTS WERE REMOVED FROM THE PATIENT. NO ADDITIONAL INTERVENTION WAS REQUIRED. HOWEVER, ADDITIONAL TIME WAS NEEDED AS THERE WAS SOME DIFFICULTY FINDING THE BROKEN PIECES INSIDE OF THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649205 ↗
• MalfunctionApr 22, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE DEVICE FELL APART IN THE PATIENT¿S WRIST. THE DEVICE AND ALL PORTIONS OF THE DEVICE WERE RETRIEVED SUCCESSFULLY. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536419 ↗