MicroFrance® CEV669BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780095088), received between Jun 17, 2025 and Jun 17, 2025 — classified as 1 injury.

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 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.

• InjuryJun 17, 2025Smoking; Arcing; No Apparent Adverse Event; Smoking; Arcing; No Apparent Adverse Event

  THIS REPORT IS 2 OF 3 FOR THE DIA 5MM ANG BIPOLAR HANDLE (CEV669B) COMPONENT OF THE INSTRUMENT AND IS RELATED TO MFG NUMBERS: 3003249645-2025-00022 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); No Clinical Signs, Symptoms or Conditions

  MAUDE report 22243868 ↗