MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HANDLE CEV669B DIA 5MM ANG BIPOLAR; PFM16

Catalog Number	CEV669B
Medical Device Problem Codes	Smoking (1585); Arcing (2583); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is 2 of 3 for the dia 5mm ang bipolar handle (cev669b) component of the instrument and is related to mfg numbers: 3003249645-2025-00022 and 3003249645-2025-00024.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.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fileds: g3, g6, h1, h2, h6, h6/f10, h11.Updated to correct h1 from serious injury to malfunction.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.It was concluded that the suspected handle cev669b dia 5mm ang bipolar (cev669b) was not associated with the reported failure.The failure analysis and root cause have been documented in the related mfg report: 3003249645-2025-00022.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d10, g3, g6, h1.Based on the reported complaint "patient burn," the type of report should be serious.
Event or Problem Description
N/a.

• Brand Name: HANDLE CEV669B DIA 5MM ANG BIPOLAR
• Common Device Name: PFM16
• 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: 22243868
• Report Number: 3003249645-2025-00023
• Device Sequence Number: 8027166
• Product Code: GEI
• UDI-Device Identifier: 10381780095088
• UDI-Public: 10381780095088
• Combination Product (Y/N): N
• PMA/510(K) Number: K210942
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2025

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: CEV669B
• Device Lot Number: 081001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 07/30/2025; 08/04/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/21/2025; 07/30/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TUBE CEV6795B DIA 5MM 350MM(CEV6795B).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown