APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CD003 |
Device Problems
Material Frayed (1262); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit was discarded; however, the lot number was provided.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 being performed: lap chole.Detailed description of event: when surgeon fully deployed the bag, the bag fell off the system, it seemed that the string was completely loose in the retriever, like not attached to the system, also the string looked frayed.Unfortunately they didnt save the system.Additional information received from "fitm" by email on 27nov2019: there is no picture available of the incident device.Patient status: no patient injury.Type of intervention: n/i.
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Event Description
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Name of procedure being performed: lap chol.Detailed description of event: when surgeon fully deployed the bag, the bag fell off the system, it seemed that the string was completely loose in the retriever, like not attached to the system, also the string looked frayed.Unfortunately they didnt save the system.Additional information received from fitm by email on 27nov2019: there is no picture available of the incident device.Patient status: no patient injury.Type of intervention: n/i.
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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 the complainant¿s experience could not be confirmed.In the absence of the event unit, it is difficult 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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Search Alerts/Recalls
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