Model Number C8XX2 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
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 performed: lap colectomy.The rep was not present during the case.During the case the surgeon was pulling on the alexis and it tore in two.Location of the damage is unknown.It is unknown if any instrumentation came in direct contact with the alexis.No patient injury.Product is available for return.Patient status: no patient injury.Type of intervention: ni.
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Event Description
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Name of procedure performed:lap colectomy.The rep was not present during the case.During the case the surgeon was pulling on the alexis and it tore in two.Location of the damage is unknown.It is unknown if any instrumentation came in direct contact with the alexis.No patient injury.Product is available for return.Additional information received via email on 18dec2020 from[name]: "i spoke with [name] today, he's decided that he does not want to send the device for evaluation based on admittance from or staff that the failure was due to the surgeon being rough with the device rather than device failure.".No product return.Additional information received via email on 05jan2020 from [name]: it is unknown what part of the alexis broke.The device was not in the patient when it broke.No pieces of the product fell into the patient.The case was completed by replacing the device.No photos are available.Patient status: no patient injury.Type of intervention: ni.
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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, the complainant's experience of a torn sheath could not be confirmed.Based on the additional information received from the complainant, it is likely that the torn event unit was caused by the excessive force exerted on the device by the user.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.The event unit was torn before the device was used in the patient.This report is to follow up medwatch report # 2027111-2020-00637.
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Search Alerts/Recalls
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