MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV136 BIPOLAR 350MM GAYET; MICROFRANCE INSTRUMENTS

Catalog Number	CEV136
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that at the end of a laparoscopic appendectomy, a thermal injury to the small bowel was observed due to an insulation defect on the forceps cev136 bipolar 350 mm gayet (cev136).No specific treatment was administered as it appeared to be a superficial wound.It was noted that the patient was readmitted three days later for abdominal pain and vomiting.A computed tomography (ct) scan was performed, but the results were inconclusive.However, analgesics and antibiotics were initiated and proved effective, and the patient was discharged in (b)(6) 2026.It is unknown if there was an increase in surgery time.
Additional Manufacturer Narrative
The forceps cev136 bipolar 350 mm gayet (cev136) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the investigation revealed no defects in the pliers.They function correctly and show no electrical leakage.Slight scratches are visible on the coating, which is normal after regular use and does not affect their operation.Root cause analysis: the patient's burn is not related to a defect in the bipolar clamp, which was found to be compliant during the investigation.The root cause is attributed to suboptimal use of the device, specifically prolonged activation and/or high coagulation power, which can lead to localized elevation in tissue temperature.

• Brand Name: FORCEPS CEV136 BIPOLAR 350MM GAYET
• 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 ; 6099362319
• MDR Report Key: 25000709
• Report Number: 3003249645-2026-00012
• Device Sequence Number: 15647725
• Product Code: GEI
• UDI-Device Identifier: 10381780091868
• UDI-Public: 10381780091868
• Combination Product (Y/N): N
• PMA/510(K) Number: K993655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CEV136
• Device Lot Number: 6631381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 09/19/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown