Model Number BD-400P-2080 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device was discarded by the customer.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined.The service center will continue to investigate this report to obtain more detailed information regarding the reported event.If additional information becomes available at a later date, this report will be updated and a supplemented accordingly.
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Event Description
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The service center was informed that during an unspecified procedure that the balloon was fully deflated and could not retracted back into the scope.The surgeon was able to remove the scope from the patient without any injury.The intended procedure was completed with the same device.Additionally, the device was inspected prior to use and no abnormalities were found.This is 1 of 2 reports.
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Manufacturer Narrative
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The oem (nordson) performed an investigation and a dhr review for the concerned device.The device was noted as not being returned; therefore, no physical investigation could be performed.The oem noted that 13 similar complaints have been received for retrieval issues in the past 12 months.However, none of the reported events could be confirmed.The dhr was review and indicated that there were no abnormalities in documentation or processes noted.The root cause was unable to be determined as the device has not been returned.
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Search Alerts/Recalls
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