Model Number CD004 |
Device Problems
Retraction Problem (1536); Difficult to Open or Close (2921); Output Problem (3005)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit is anticipated to return for evaluation.A follow-up will be provided upon completion of the investigation.This report is a follow up to mw5110321.
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Event Description
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Type of procedure: laparoscopic oophorectomy description of event: "laparoscopic oophorectomy attempted using the inzii retrieval system.The laparoscopic retrieval bag failed to deploy correctly and would not open.The bag was unable to be retracted, requiring cutting of the [invalid]; additional incision was required to remove the bag from inside the patient." product is available for return.Patient status: no report of patient injury.Type of intervention: additional incision was required to remove the bag from inside the patient.
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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.This report is a follow up to mw5110321.
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Event Description
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Type of procedure: laparoscopic oophorectomy.Description of event: "laparoscopic oophorectomy attempted using the inzii retrieval system.The laparoscopic retrieval bag failed to deploy correctly and would not open.The bag was unable to be retracted, requiring cutting of the [invalid]; additional incision was required to remove the bag from inside the patient." product is available for return.Patient status: no report of patient injury.Type of intervention: additional incision was required to remove the bag from inside the patient.
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Search Alerts/Recalls
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