MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD C AND T SET FLYING LEADS RP BULK; DISPOSABLE CODMAN CORD AND TUBING

Catalog Number	9190002RPB
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported a disposable codman cord and tubing (id 9190002rpb) sparked during use.The bipolar forceps were removed from sterile field, new bipolar cord was retrieved, as well as a new generator.Surgery was continued and no other problems were noted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The disposable codman cord and tubing (id 9190002rpb) was not returned for evaluation (sample is not available for return) and lot number information has not been provided; but a photo was provided that the device was no longer connected to the setup.There were no visual scorch marks on the product therefore the image attached could not be used to confirm the complaint.Root cause analysis - potential root causes for this failure mode per the risk documentation, include inappropriate insulation thickness, material or dimensions/tolerance.

• Brand Name: C AND T SET FLYING LEADS RP BULK
• Common Device Name: DISPOSABLE CODMAN CORD AND TUBING
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23782481
• Report Number: 3014334038-2025-00150
• Device Sequence Number: 17413613
• Product Code: GEI
• UDI-Device Identifier: 10381780521785
• UDI-Public: 10381780521785
• Combination Product (Y/N): N
• PMA/510(K) Number: K163106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 9190002RPB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown