MAUDE Adverse Event Report: Integra MicroFrance S.A.S. FORCEPS CEV134 BIPOLAR 350MM MOUIEL; Microfrance Instruments

Catalog Number	CEV134
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.".
Additional Manufacturer Narrative
The forceps cev134 bipolar 350mm mouiel (cev134) was not returned for evaluation: the device history record (dhr): unable to review the applicable dhr as the batch no.Was unavailable failure analysis: product or objective evidence was not returned so the evaluation was unable to be performed.Therefore, an investigation for cause was unable to be performed.Potential root cause analysis: the problem may stem from the clamp (manufacturing defect, wear, or improper assembly) or from another component of the system, such as the cable or the generator.Without batch identification or analysis of the instrument, it is impossible to determine the exact cause of the malfunction.

• Brand Name: FORCEPS CEV134 BIPOLAR 350MM MOUIEL
• Common Device Name: Microfrance Instruments
• Manufacturer (Section D): Integra MicroFrance S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): Integra MicroFrance S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50841652
• Report Number: 3003249645-2026-00041
• Device Sequence Number: 10270219
• Product Code: GEI
• UDI-Device Identifier: 10381780091837
• UDI-Public: 10381780091837
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CEV134
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown