MAUDE Adverse Event Report: RAYNHAM C AND T SET FIXED LEADS GF; DISPOSABLE CODMAN CORD AND TUBING

Catalog Number 9190001GF

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported electrical failure of the bipolar cords during procedure, prior to patient use.The procedure was completed with a replacement product and 30 minutes surgical delay was reported due to product failure.No patient injury or consequences reported.

Manufacturer Narrative

The bipolar cord 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 multimeter was used to measure the resistance between the pin end and the socket end.Conductance was observed for both socket/pin pair.Therefore, the complaint was not confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

Event Description

N/a.

• Brand Name: C AND T SET FIXED LEADS GF
• Type of Device: DISPOSABLE CODMAN CORD AND TUBING
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11096885
• MDR Text Key: 226780156
• Report Number: 3014334038-2020-00128
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K163106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 9190001GF
• Device Lot Number: J2158U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1