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Model Number SCORPION-MULTIFIRE NEEDLE |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that the tip of the ar-13995n, scorpion multifire needle broke off during the operation inside the patient.The tip could not be retrieved and remains in the patient.The facility reported that the device is available to return for evaluation.No further details were provided.
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Manufacturer Narrative
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The failure mode could not be determined, but the broken needle point condition can be caused by consistently 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.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.
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Search Alerts/Recalls
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