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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
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
Medwatch#: (b)(4).A facility reported: "during procedure, the mallis irrigating tubing for the bipolar was malfunctioning.Multiple tubing pulled from stock with same lot number were opened and non-functioning.All this tubing was discarded.Once a new lot number was opened, there were no further issues identified.The team pulled all stock with affected lot number and worked with field representative on replacing used stock item.No further events have been reported to date." no patient injury reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h1, h2, h3, h6, h11.The bipolar irrigating tubing (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 - the unit was evaluated using a continuity test per test method.The complaint was verified through failure analysis.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• 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: 21895206
• Report Number: 3014334038-2025-00056
• Device Sequence Number: 3434191
• 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): 08/20/2025

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: 7358847
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White