NA 03.503.037Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587011639), received between Feb 7, 2017 and Apr 22, 2025 — classified as 6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTERS DID NOT WORK; IT WAS BROKEN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886548 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MESH CUTTER SCISSOR BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268938 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE HANDLE OF MESH CUTTER WAS BROKEN. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) MESH CUTTING SCISSORS LONG NOSE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19251012 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN SETTING UP FOR THE PROCEDURE PRIOR TO PATIENT INTERACTION, IT WAS BROUGHT TO ATTENTION THAT THE MESH CUTTERS WERE BROKEN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) UNK: CUTTING INSTRUMENTS: TRAUMA. THIS IS REPORT 1 OF 1 FOR COMPLAINT : (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720459 ↗
• MalfunctionMar 10, 2017Break; Break

  IT WAS REPORTED THAT ONE OF MESH CUTTING SCISSORS LONG NOSE BLADES HAS BROKEN OFF. THE BROKEN PIECE HAS BEEN LOCATED. THE ISSUE WAS DISCOVERED IN STERILE PROCESSING. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6397590 ↗
• MalfunctionFeb 7, 2017Break; Break

  IT WAS REPORTED AS THE MESH WAS CUT DURING A FACIAL RECONSTRUCTION PROCEDURE ON (B)(6) 2017, ONE OF THE TWO (2) INSTRUMENT ARMS BROKE ON FOUR (4) MESH CUTTING SCISSORS, RENDERING THEM UNUSABLE. IT WAS CONFIRMED THAT FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICES DURING THE PROCEDURE. THE FRAGMENTS WERE EASILY REMOVED WITHOUT DELAY OR ANY ADDITIONAL INTERVENTION REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: MESH (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6309099 ↗