Model Number CD001 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
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Event Description
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Procedure performed: ni event description: limited information is available at the time of report as the event happened in 2019.During the case the surgeon stated that they spent approximately an hour searching for a piece of plastic that broke off from the bag before they were able to remove it.There was no patient injury.Product is not available for return.Intervention: ni patient status: no patient injury reported.
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
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Event Description
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Procedure performed: ni event description: limited information is available at the time of report as the event happened in 2019.During the case the surgeon stated that they spent approximately an hour searching for a piece of plastic that broke off from the bag before they were able to remove it.There was no patient injury.Product is not available for return.Intervention: ni patient status: no patient injury reported.
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Search Alerts/Recalls
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