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Catalog Number MCM20 |
Device Problems
Failure to Fire (2610); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 12/27/2023.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 a pancreaticoduodenectomy procedure, the device kept jamming then slicing through vessel.Opened single packed clips in the end.Mechanism locked out and staple wouldn¿t move into the jaws, then when it move into the jaws the clip cut the vessel.Vessel may have been thin.No patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 2/13/2024.D4: batch # a9cx5f.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 mcm20 device was received with no damage in the external components.In an attempt to replicate the reported incident; the device was cycled, resulting in one(1) partially-formed clip due to an anti-backup failure.The remaining five(5) clips were fed and formed as intended.Finally, the instrument locked out.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling, the antibackup lever was found worn out.It is possible this condition was caused by attempting to squeeze the device handle when it was not fully returned or by stopping the firing sequence and pulling the handle open.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.
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Search Alerts/Recalls
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