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).H6 component code: g07002 - device not returned.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 photo analysis:this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows an apparently broken needle held by the user.The image is not clear to determine the failure mode or the reported condition.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that a patient underwent a bypass procedure on (b)(6)2023 and suture was used.During the procedure, it was reported that the problem of pulling off suture needle occurred during using for monitoring in a bypass surgery.Enclosed please find defect photo.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.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17167944
• MDR Text Key: 317656049
• Report Number: 2210968-2023-04467
• 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
• Report Date: 06/20/2023

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
• Device Operator: Health Professional
• Device Model Number: TPW20
• Device Catalogue Number: TPW20
• Device Lot Number: SKBHBJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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