Model Number BH145R |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that there was an issue with bh145r - crile forceps cvd 140mm.According to the complaint description, the crile(s) broke.There was unknown patient harm.Additional details have been requested.The adverse event / malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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Update: the patient harm was confirmed to be "no", updated from "unknown".
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Manufacturer Narrative
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Upon review of the updated patient harm, the complaint has been re-assessed and is now considered to be non-reportable.
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Search Alerts/Recalls
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