MicroFrance® CEV634-1ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780094678), received between Feb 11, 2025 and Dec 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Break; Break

  A FACILITY REPORTED THAT BIPOLAR FORCEPS OF THE BIPOLAR INSERT CEV634-1A 350MM MOUIEL (CEV634-1A) BROKE INSIDE THE PATIENT DURING AN OPERATION. IT WAS REPORTED THAT THE BREAK OCCURRED AT THE TIP OF THE INSERT, A SINGLE PIECE DETACHED AND WAS RECOVERED, AND ANOTHER FORCEPS WERE USED TO COMPLETE THE SURGERY. THERE WAS NO INJURY, DEATH, AND IT WAS UNKNOWN IF THERE WAS ANY INCREASE IN SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834997 ↗
• InjuryJun 17, 2025Smoking; Arcing; No Apparent Adverse Event; Smoking; Arcing; No Apparent Adverse Event

  THIS REPORT IS 3 OF 3 FOR THE DIA 5MM 350MM TUBE (CEV6795B) COMPONENT OF THE INSTRUMENT REPORTEDLY USED DURING THIS EVENT, AND IS RELATED MFG NUMBERS: 3003249645-2025-00022 AND 3003249645-2025-00023. 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 22243399 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT THE 350MM MOUIEL BIPOLAR INSERT ((B)(6)) BROKE IN THE PATIENT'S ABDOMEN AND WAS DIFFICULT TO RETRIEVE. ANOTHER DEVICE WAS AVAILABLE TO FINISH THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360611 ↗
• MalfunctionFeb 11, 2025Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360610 ↗