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Catalog Number ER420 |
Device Problems
Mechanical Problem (1384); Failure to Form Staple (2579)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a gastric bypass procedure that the clips were consistently scissoring on the small bowel and gastric staple lines.The clips looked uneven in the jaws prior to ejection.Unknown as to how the procedure was completed.There were no adverse consequences reported.
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Manufacturer Narrative
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(b)(4).Date sent: 12/21/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.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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Manufacturer Narrative
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(b)(4).Date sent: 1/22/2024.D4: batch # x7040c.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.In addition, two(2) scissored clips were returned inside a plastic bag along with the instrument.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 seventeen(17) scissored clips due to the misaligned condition of the jaws; finally the instrument locked out as intended.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met before the release of this batch.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 x7040c number, and no non-conformances were identified.
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Search Alerts/Recalls
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