|
Model Number TPW32 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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.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.Could you please confirm what was the exact issue? did the suture got broken? did the suture got separated from the needle? what is the lot number? what is the current condition of the patient? could you please confirm device availability? what was the initial procedure? when did the issue occurred? pre op, intra op or post op.
|
|
Event Description
|
It was reported that a patient underwent an unknown procedure on 04/01/2021 and suture was used.During the procedure, per user facility medwatch form, (b)(4), during a temporary pacing, epicardial wire broke where it insert into the needle.There were no patient consequences reported.Additional information was requested.
|
|
Manufacturer Narrative
|
(b)(4).Date sent to the fda: 8/10/2021.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.Additional information was requested and the following was obtained: product should of been returned, the customer has sent or is sending the defective product back, the lead wires break in patients after they have already been implanted.No one died, no one was injured.The product seems like a bad batch.That is all the information they have.(b)(4).Date sent to the fda: 8/10/2021.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.
|
|
Search Alerts/Recalls
|
|
|