Integra® MicroFrance® MCL15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780105053), received between Aug 17, 2023 and Aug 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Biofilm coating in Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2023Biofilm coating in Device; Biofilm coating in Device

  IT WAS REPORTED THAT BIOBURDEN WAS FOUND IN THE JAWS OF THE ALLIG LFT BOUCHAYER FORCEPS (MCL15) WHEN THE INTEGRA SALES SPECIALIST CHECKED THEM IN. THE LOANER POOL INSTRUMENT WAS UNPACKED AND INSPECTED AND THE CONTAMINATION WAS DISCOVERED. THE CUSTOMER WAS MADE AWARE AND CLEANED THE INSTRUMENT BEFORE USE AT THE HOSPITAL. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17566563 ↗