MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR C AND T SET FIXED LEADS GF; DISPOSABLE CODMAN CORD AND TUBING

Catalog Number	9190001GF
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported a disposable codman cord and tubing (id 9190001gf) had intermittently unstable output or would not turn on when connecting to the main device.The main device and bipolar forceps were replaced alternately.Despite these efforts, the issue persisted, and the product was replaced without improvement.Upon connecting a third cord, the device functioned properly.No adverse consequences to the patient were observed.However, the incident resulted in a surgical delay of more than 30 minutes.Based on additional information provided, it is unknown whether the "main device" and "bipolar forceps" involved were integra products.
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 fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The disposable codman cord and tubing (id 9190001gf) 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 - a continuity test was performed using fluke multimeter.The complaint was confirmed.The measured resistance did not meet the specified acceptance criterion: cable assembly shall not exhibit more than 2 ohms resistance from receptacle socket contacts when tested.The recorded measurement was 11.6 ohms on the right receptacle socket for the left pin end, exceeding the 2 ohms limit.During visual inspection, the receptacle socket exhibited noticeable discoloration.Evidence of arcing damage, including scorching and charring, was observed on the connector.Root cause analysis - the potential root causes for this failure mode per the risk documentation, inadequate material selection or improper dimensions (exposed pin length insufficient for electrical connection), improper crimp tool setup, damaged wire, and corrosion.

• Brand Name: C AND T SET FIXED LEADS GF
• Common Device Name: DISPOSABLE CODMAN CORD AND TUBING
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22677263
• Report Number: 3014334038-2025-00106
• Device Sequence Number: 8937456
• Product Code: GEI
• UDI-Device Identifier: 10381780521730
• UDI-Public: 10381780521730
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 9190001GF
• Device Lot Number: 7374854
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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