|
Catalog Number ER320 |
Device Problems
Difficult to Open or Close (2921); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/01/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during a laparoscopic procedure, the clip could not be fed into the jaw.Then the jaw could not be opened.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: (b)(6) 2023 b3: unknown, assumed first day of month that complaint was reported d4: batch # unk.Additional information was requested and the following was obtained: "were the device jaws eventually opened? - currently, unknown.Was the device on tissue when it would not open? - currently, unknown.If yes, how was the device removed from the tissue? - n/a.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).- currently, unknown." 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: 2/9/2024.D4: batch # a9c56t.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 revealed that the er320 device was returned with the jaws closed and with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the trigger could not be activated due to be jammed.The device was disassembled to evaluate the condition of the internal components and the trigger was found bent, not allowing the clips to fed into the jaws.In addition, twenty(20) clips were found remaining inside the clip track.The damaged on the device could be that the internal ribs were being gauged by the feeder link, causing the trigger to experienced additional force that could interfere with the firing of the device.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
|
|
Search Alerts/Recalls
|
|
|