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(b)(4).Date sent: 8/10/2026.D4: batch #911d44.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:
1.Was the firing sequences started? if yes, was the firing sequence completed?
2.Did the device deliver any staples?
3.If yes, were the staples formed properly?
4.What was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)?
5.Were there staples missing from the staple line?
6.Did the device cut?
7.If yes, was the cut line complete?
8.If yes, was there any issue with the cut line?
9.Was there any difficulty opening the device jaws?
10.If yes, what steps were taken to open the jaws.11.If the jaws could not be opened, how was the device removed.12.Was there a patient consequence? if yes, how was the issue addressed?
13.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event?
investigation summary:
the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one pve35a device was returned with no apparent damage and with no reload present.The manual override door out of position and missing; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequence firings.The bailout system was reset and then an attempt to fire the device was made, however, the device would not fire.Upon evaluation, the pcb board was noted to be non-functional.No conclusion could be reached as to what may have caused the pcb board to be damaged.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch
as part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 911d44, and no non-conformances were identified.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.
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