Model Number N/A |
Device Problems
Device Reprocessing Problem (1091); Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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It was reported that a distributorship is returning multiple versa-dial trial adaptors for repair.The o-rings weakened after being sterilized several times, causing them to fracture during washing.The damaged items were not used during any surgical procedures.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under precautions, it states, "surgical instruments are subject to wear with normal usage." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.The following sections could not be completed with the limited information provided.Date of event ¿ unknown.This report is number 2 of 5 mdrs filed for the same event (reference 1825034-2015-02459 / 02463).
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Manufacturer Narrative
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The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted that the root cause of the event was most likely the age of the device and wear caused by repeated sterilizations.Device most likely failed due to the device not being inspected for wear and disfigurement prior to use, which may have prevented the use of the instrument and its failure.
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Search Alerts/Recalls
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