MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TUBE CEV649-5B DIA 5MM 350MM; PFM16

Catalog Number	CEV649-5B
Medical Device Problem Codes	Smoking (1585); Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is 1 of 3 for the dia 5mm 350mm tube (cev649-5b) component of the instrument and is related to mfg numbers: 3003249645-2025-00023, 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
The tube cev649-5b dia 5mm 350mm (cev649-5b) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the tube cev649-5b dia 5mm 350mm was received in used condition.Upon further inspection, it was discovered that the sheath had scratches.There was an impact related to the electric arc, as indicated by the customer, which caused the sheath to melt.The scratches were adjacent to the melted impact.The instrument has been repaired and reprocessed by a service provider other than integra-microfrance (imf) "petel" on several occasions.The sheath present on the tube was not a component replaced by imf.Root cause analysis: the reported complaint was confirmed.The coating was damaged, which affected the insulation.There was contact with another instrument, creating an electric arc.We cannot guarantee the nature of the sheath supplied by an external service provider.Imf recommends repairs within its factory and cannot guarantee the services provided by an external service provider.
Event or Problem Description
N/a.

• Brand Name: TUBE CEV649-5B DIA 5MM 350MM
• 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: 22243387
• Report Number: 3003249645-2025-00022
• Device Sequence Number: 18186966
• Product Code: GEI
• UDI-Device Identifier: 10381780094876
• UDI-Public: 10381780094876
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: CEV649-5B
• Device Lot Number: 151005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2015
• 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: Other
• Patient Sex: Unknown