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

Model Number TPW20

Device Problem Break (1069)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, it was reported that the suture was found broken when the package was opened for an unknown surgery on (b)(6) 2021.Another like device was used to complete the procedure.No adverse patient consequences were reported.No additional information was provided.

• 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 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11734688
• MDR Text Key: 249374204
• Report Number: 2210968-2021-03862
• 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,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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: QHBAUU
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2021
• 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
• Patient Age: 62 YR