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Catalog Number AR-13995N |
Device Problems
Break (1069); Component Missing (2306); Failure to Advance (2524); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
No Information (3190)
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Event Date 04/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The typical cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.
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Event Description
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It was reported that while attempting to pass suture, the scorpion device was not passing the suture.The scorpion device was removed and it was discovered the tip of the multifire scorpion needle was missing.Rep does not know if the tip is in the patient; the surgeon did not want to check with x-ray.
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Manufacturer Narrative
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Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission due to evaluation.The failure mode could not be determined but the broken needle point condition is consistent with passing the needle through challenging tissue (thick or calcified) or hitting bone.The buckled needle strip condition is typically caused by the device skiving under thick tissue or distorting distally under the jaw.The distal end of the nitinol point demonstrated minimal scrape marks, indicating the device was not fired excessively.The mating part (instrument) was not returned or identified.Confirmed the needle strip thickness and width dimensions to be within specification.The typical cause for this type of event is the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
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Event Description
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It was reported that while attempting to pass suture, the scorpion device was not passing the suture.The scorpion device was removed and it was discovered the tip of the multifire scorpion needle was missing.Rep does not know if the tip is in the patient; the surgeon did not want to check with x-ray.
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Search Alerts/Recalls
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