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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 03/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) date sent: 4/16/2024 d4: batch # unk an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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 clips cross and therefore clipping fails.No patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 5/21/2024.D4: batch # x7046j.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 apparent damage.The device was tested for functionality.During the analysis, the device was noted with fluids.The device was functional tested, and it fed, retained and formed the remaining twenty clips(20) clip as intended.In order to evaluate the condition of the internal components of the device had it was disassembled.Upon disassembling, no anomalies were found.The event described could not be confirmed as the device performed without any difficulties noted.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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