Integra® MicroFrance® CP391MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780099512), received between May 29, 2025 and May 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Explosion” (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.

• MalfunctionMay 29, 2025Overheating of Device; Explosion; Material Split, Cut or Torn; Overheating of Device; Explosion; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS AND ARTHROPLASTY CHANGE OPERATION, THE 3.5M MONOPOLAR MARTIN CABLE (CP391M) EXPLODED AND THE TIP WAS CUT. IT WAS SUBSEQUENTLY REPORTED THAT WHILE USING THE MONOPOLAR ELECTRIC SCALPEL WITH A MULTI-PURPOSE TIP, IT "EXPLODED." IT WAS NOTED THAT THE POWER CABLE BETWEEN THE ELECTRIC SCALPEL, AND THE GENERATOR HAD A BROKEN THREAD. A SMALL "EXPLOSION" WAS HEARD, AND OBSERVANTLY, IT WAS NOTED THAT THE ELECTRIC SCALPEL CABLE HAD BEEN CUT (OVERHEATING?) NEAR THE HANDPIECE (OF THE MONOPOLAR ELECTRIC SCALPEL TIP). IT WAS REPORTED THAT THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY, DEATH, OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106220 ↗