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

Model Number TPW20

Device Problem Material Separation (1562)

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

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.H3 device analysis:the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received one needle and suture that pertain to product code tpw20.In addition, the suture was not received.Upon visual analysis of the returned needle, the barrel hole was examined under 20x magnification, and no remnant suture was found.Also, the suture was not received for analysis.Due to returned condition of the sample cannot functional test was performed.

Event Description

It was reported that a patient underwent a valve replacement procedure on (b)(6) 2023, and suture was used.During the procedure.It was reported that the problem of pulling off suture needle (straight needle) occurred during using for monitoring.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: TPW 24IN 2-0 D/A BB,SKS BWY
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17167947
• MDR Text Key: 317527719
• Report Number: 2210968-2023-04466
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050877
• UDI-Public: 10705031050877
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPW20
• Device Catalogue Number: TPW20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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