Model Number C8322 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Engineering is investigating the returned unit.A follow up report will be sent once the results have been analyzed.
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Event Description
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Procedure performed: breast procedure.Limited information provided.Email that was sent by facility stated that alexis is arriving with holes in it.Discovered during surgery and completed the case with the event device.This did not delay or time.There are no photos available.Product will be returned.Additional information received via phone on 14aug2019 from applied medical account mgr.The holes were in the sheath of the alexis.They did not notice the holes until they removed the alexis at the end of the case.The surgeon has been using the alexis for 2 to 3 years with the mini richardson retractors and has not had an issue.Intervention: completed with same device as holes were not found until after the case was completed.Patient status: no patient injury.
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Event Description
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Procedure performed: breast procedure.Detailed description of event: limited information provided.Email that was sent by facility stated that alexis is arriving with holes in it.Discovered during surgery and completed the case with the event device.This did not delay or time.There are no photos available.Product will be returned.Additional information received via phone on 14aug2019 from applied medical account mgr.The holes were in the sheath of the alexis.They did not notice the holes until they removed the alexis at the end of the case.The surgeon has been using the alexis for 2 to 3 years with the mini richardson retractors and has not had an issue.Type of intervention: completed with same device as holes were not found until after the case was completed.Patient status: no patient injury.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.The complainant's experience could not be confirmed as engineering did not observe any sheath tears or other non-conformances.Applied medical has reviewed the details surrounding the event and related product and is unable to confirm that a product malfunction occurred, as the event unit met current specifications.
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Search Alerts/Recalls
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