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

Catalog Number	9190002RP
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch # (b)(4).A facility reported: "codman irrigating bipolar was irrigating but not cauterizing.When the cord was switched out, the device (handpiece and console) worked appropriately." the product problem was discovered during the procedure when trying to stop a bleed.
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
N/a.
Additional Manufacturer Narrative
Updated fields : d4, d8, d9, g6, h1, h2, h3, h4, h6, h11.The codman irrigating bipolar (9190002rp) was returned for evaluation device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - specimen failed continuity testing due to resistance exceeding the 2-ohm limit, confirming the complaint.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Potential root causes for this failure mode per the risk documentation, include: "inadequate material selection or improper dimensions (exposed pin length insufficient for electrical connection)".

• Brand Name: C AND T SET FLYING LEADS RP
• 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: 21773368
• Report Number: 3014334038-2025-00048
• Device Sequence Number: 18192814
• Product Code: GEI
• UDI-Device Identifier: 10381780521778
• UDI-Public: 10381780521778
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9190002RP
• Device Lot Number: 7358846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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