Integra® MicroFrance® CEV649-5BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780094876), received between Jun 17, 2025 and Mar 23, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Arcing” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Overheating of Device

  THIS IS 1OF 3 REPORTS AND IS RELATED TO MFG NUMBER 3003249645-2026-00007: A FACILITY REPORTED THAT A BURN OCCURRED ON A PATIENT DURING A LAPAROSCOPIC REPAIR OF ABDOMINAL WALL HERNIA ASSOCIATED WITH AN UMBILICAL HERNIA, WITH MESH PLACEMENT, INVOLVING THE TUBE CEV649-5B DIA 5MM 350MM (CEV649-5B). THE PATIENT SUSTAINED A SUPERFICIAL BURN, WHICH HAS RESULTED IN A SMALL BURN SCAR. THE HEALTHCARE FACILITY PROVIDED LOCAL CARE AND MONITORING OF THE PATIENT, AND THE MEDICAL DEVICE WAS QUARANTINED. THERE WAS NO REPORT OF AN INCREASE IN SURGICAL TIME.

  Patient problems: Burn(s)

  MAUDE report 24661775 ↗
• InjuryJun 17, 2025Smoking; Arcing; Smoking; Arcing

  THIS REPORT IS 1 OF 3 FOR THE DIA 5MM 350MM TUBE (CEV649-5B) COMPONENT OF THE INSTRUMENT AND IS RELATED TO MFG NUMBERS: 3003249645-2025-00023, AND 3003249645-2025-00024. A FACILITY REPORTED THAT DURING A COELIOSCOPY SURGERY, BLACK SMOKE APPEARED DURING FIRST USE OF THE LAPAROSCOPY SHEATH. AN ELECTRIC ARC OCCURRED WHICH BURNT THE WALL OF THE PATIENT'S ABDOMINAL CAVITY. THE INJURY WAS DESCRIBED AS A 1-CENTIMETER (CM) BURN OF THE PERITONEUM, AT THE OPPOSITE JUNCTION OF THE ANTERIOR AND LATERAL ABDOMINAL WALL OF THE ILIAC FOSSA. IT WAS REPORTED THAT NO TREATMENT WAS NEEDED; HOWEVER, BLACK DEBRIS FROM THE SHEATH THAT HAD SETTLED ON THE PERITONEUM WAS SUCTIONED OUT. A SINGLE-USE COELISCOPIC SCISSORS WAS USED AS A REPLACEMENT TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THERE WAS NO FURTHER CONSEQUENCE TO PATIENT AT DAY 1 AND BEYOND. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 22243387 ↗