Model Number C6001 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
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Event Description
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Procedure performed: lap appendix.During procedure, suction handpiece tip blocked with a metal piece and it came off when they started suctioning.Item from the lap appendix kits.Previous cer ((b)(4)).Intervention: ni.Patient status: patient is fine, and completely unaffected.
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Manufacturer Narrative
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This follow-up report corrects the reporter's country to (b)(6).The previous report stated it was united states.
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Event Description
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Procedure performed: lap appendix.During procedure, suction handpiece tip blocked with a metal piece and it came off when they started suctioning.Item from the lap appendix kits.Intervention: ni.Patient status: patient is fine, and completely unaffected.
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Event Description
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Procedure performed: lap appendix.During procedure, suction handpiece tip blocked with a metal piece and it came off when they started suctioning.Item from the lap appendix kits.See photos on previous (b)(4).Intervention: ni.Patient status: patient is fine, and completely unaffected.
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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, testing was unable to be performed and applied medical was unable to confirm or replicate the complainant¿s experience.In the absence of the event unit, applied medical is unable 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 nature of the failure and 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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Search Alerts/Recalls
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