|
Catalog Number LT200 |
Device Problems
Unintended Ejection (1234); Failure to Form Staple (2579)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/10/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during a vasectomy procedure, the needed to take out extra magazines of clips.The clips where sometimes formed an "s" already in the magazine, sometimes the clips just fell out of the magazine.No surgical delay.Procedure completed successfully.No patient consequences.
|
|
Manufacturer Narrative
|
(b)(4).Date sent: (b)(6) 2023.D4: batch # unk.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.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
|
|
Manufacturer Narrative
|
(b)(4).Date sent: 1/17/2024.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number 410c54, and no non-conformances were identified.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.D4.Lot.
|
|
Search Alerts/Recalls
|
|
|