Model Number 10-401FC |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 01/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
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Event Description
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It was reported that during a myosure procedure, the myosure control unit went black and needed to be reset.When the myosure device was removed from the patient the physician observed a piece of the blade was missing.The fragment was estimated to be the size of a few grains of sand, which broke off in the cavity and could not be located.It was not possible to find the fragment in the cavity via hysteroscopy.The physician notified pathology should the fragment be identified from the tissue trap.There was no injury to the patient reported at the time, no medical interventions were performed.Pathology confirmed that the metal fragment from the blade was found within the tissue trap.
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Manufacturer Narrative
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Device received and visually inspected only for reported complaint.Visual examination showed evidence of blade exit during procedure.Blade fragmentation and other blade damage locations along blade edge noted with a strike mark/gouge on cutting window rim in the 12 o'clock position observed.Findings indicate excessive force applied to device during biospy, which likely caused reported issue.This observation will be monitored and trended.
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Search Alerts/Recalls
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