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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 01/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 4/16/2024.D4: batch # a9cx9m.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 er420 device was returned with no damage in the external components. upon cycling, the device was noted to be empty and the lockout had been fired through. the instrument was disassembled in order to evaluate the condition of the internal components and the latch posts was noted to be broken, which denotes that the lockout had been fired through.Please note the device contains a lockout feature that is designed to increase the required force it takes to close the trigger once the last clip has been fired; this reduces the possibility of empty jaws being closed on a structure.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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Manufacturer Narrative
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(b)(4).Date sent: 4/11/2024.D4: batch # unk.Additional information was requested and the following was obtained: "is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) patient doing well ¿ no patient consequence".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 bariatric procedure, the clips scissor and not appose when clipper is fired.
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Search Alerts/Recalls
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