DEPUY SYNTHES PRODUCTS LLC COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Reporter¿s phone number was not provided.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device seized, jammed, moved heavily and was defective due to prolonged exposure to liquid.The device also failed pretest for check the oscillation angle, check switching function, check the triggers and electronic control unit (ecu) function, check compatibility between colibri/sbd and colibr ii/sbd ii and check the function with electric pen drive (epd)-console.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to device use which is user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that the small battery drive device did not work.According to the report, the device stopped working about thirty seconds after starting.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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