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Catalog Number ER420 |
Device Problem
Failure to Form Staple (2579)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 12/28/2023 d4: batch # unk a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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Event Description
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It was reported that during an unknown procedure, the formation of the clip was incorrect as the clip was scissoring.This did happen repeatedly with 5/6 firings which then resulted in the surgeon removing the device and switching to another clip applier i.E hem-o-lok to complete the procedure.This is a very experienced surgeon with this device and he was not using it in any unusual conditions and certainly had not applied any additional force or tension.The patient has not come to any harm in this procedure.
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Manufacturer Narrative
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(b)(4).Date sent: 2/12/2024.D4: batch # x7033v.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 er420 device was returned with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found to be misaligned and yielded.In addition, the tyvek was returned along with the instrument and one(1) scissored clip inside a plastic bag.In an attempt to replicate the reported incident, the device was tested for functionality; during the analysis, the instrument was cycled and it fed and formed five(5) scissored clips due to the misaligned condition of the jaws; finally the instrument locked out as intended.The event reported was confirmed and it is related to improper use of the device.Possible causes for the condition found may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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Search Alerts/Recalls
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