|
Catalog Number EL5ML |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/01/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4) date sent: 4/23/2024 b3: unknown, assumed first day of month that complaint was reported 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.
|
|
Event Description
|
It was reported that during an unknown procedure, the jaws were deformed.It was not able to enter through the port.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
|
|
Manufacturer Narrative
|
(b)(4).Date sent: 5/23/2024.D4: batch # c9d64c.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was returned with one jaw disengaged from the cam; this condition would not allow the jaws to collapse in order to form the clips.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.In order to evaluate the performance of the device, the jaw was readjusted and in the next actuations, two(2) conforming clips were fed and formed; finally the device locked out as intended.However, it is known from the history of the device that the jaw disengaged condition may lead to malformed clips.Possible causes for the condition of the jaw disengaged from the cam may be inadvertent force, twisting or pressure being placed on the device jaws, using the jaws of the device as a dissector/retractor or damage to the jaws while entering the trocar.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
|
|
Search Alerts/Recalls
|
|
|