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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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