MicroFrance® CEV134Recalls & reported problems
Integra Microfrance · Mouiel Bipolar Forceps with Fenestrated Jaws · Class 2
All models of MicroFrance (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780091837), received between Apr 22, 2025 and Sep 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Energy Output Problem” (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.
Reports received per month
Most reported problems
Device problems
- Energy Output Problem1
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Energy Output Problem
A facility reported that a patient who was at high risk for bleeding was scheduled for cholecystectomy following biliary pancreatitis, using the FORCEPS CEV134 BIPOLAR 350MM MOUIEL (CEV134). It was reported that "the surgeon observed suboptimal tissue coagulation. The malfunction persisted despite replacing the cables with new ones and changing the generator. A second forceps was then used successfully to complete the procedure." Although no patient injury was reported, "the incident resulted in poor tissue coagulation efficiency and hemorrhagic dissection, leading to an extension of the procedure by approximately 2 hours. The postoperative course was uneventful; however, the patient was exposed to a significant risk of major hemorrhage.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841652 ↗MalfunctionApr 22, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT WHEN THE BLADES OF THE 350MM MOUIEL BIPOLAR FORCEPS (CEV134) WERE BROUGHT TOGETHER TO COAGULATE, THEY DO NOT CLOSE PROPERLY IN PARALLEL, THUS AFFECTING THEIR ACTION. IT WAS REPORTED THAT BECAUSE THE FORCEPS WAS NOT WORKING, THERE WAS AN INCREASE IN SURGERY TIME OF MORE THAN 30 MINUTES. IT WAS REPORTED THAT STAFF USED BIPOLAR FORCEPS FROM THE COMPETITOR TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR DEATH WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885243 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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