Model Number CD001 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/04/2020 |
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 report will be provided upon completion of the investigation.
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Event Description
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Name of procedure: laparoscopic cholecystectomy.Detailed description of event: the inzii device was used to remove the sample from the patient.After the sample was removed the abdomen was examined and it was found that a piece of the inzii bag was left behind in the patient.The piece was retrieved by the surgical team.No leakage was reported from the bag.The metal prongs were not exposed within the patient.No patient injury.The product is available for return.A photo of the product has been provided.Patient status: no patient injury.Type of intervention: piece of the bag was retrieved from the patient.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Engineering observed that the tissue bag was torn underneath the cuff and a portion of the tissue bag had fragmented.The cord loop was also cut cleanly.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the root cause based on the evaluation of the returned unit.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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Name of procedure: laparoscopic cholecystectomy.Detailed description of event: the inzii device was used to remove the sample from the patient.After the sample was removed the abdomen was examined and it was found that a piece of the inzii bag was left behind in the patient.The piece was retrieved by the surgical team.No leakage was reported from the bag.The metal prongs were not exposed within the patient.No patient injury.The product is available for return.A photo of the product has been provided.Additional information received via email on 09sep2020 from [name]: the port site was not enlarged before removal of the specimen.There were no difficulties noted with the removal of the specimen.Patient status: no patient injury.Type of intervention: piece of the bag was retrieved from the patient.
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Search Alerts/Recalls
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