MAUDE Adverse Event Report: ETHICON INC. TPW 24IN 2-0 D/A RB-1,SKS BWY; ELECTRODE, PACEMAKER, TEMP

Model Number TPW10

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: do you mean the product was found to be broken? or product was found to be separated from cable plug? lot number? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent a pacemaker surgery on (b)(6) 2022 and suture was used.During a pacemaker rewiring upon assessment of atrial electric plugs the product was found to be broken off inside patient cable plug.The patient wire had to be stripped and rewired to connect back to pacer.There were no patient consequences reported.Additional information was requested.

• Brand Name: TPW 24IN 2-0 D/A RB-1,SKS BWY
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14777645
• MDR Text Key: 296253366
• Report Number: 2210968-2022-04747
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050860
• UDI-Public: 10705031050860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPW10
• Device Catalogue Number: TPW10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1