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Model Number ER320 |
Device Problem
Firing Problem (4011)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.The following additional information was obtained: "no patient consequence, a short delay of surgery".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 doctor had a failed installation with a ligaclip.The handle broke trying to place a clip.No patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 12/23/2022.D4: batch#: p9445r.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 received with the trigger broken and not returned.The device was disassembled to evaluate the condition of the internal components and 19 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 lot and batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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