DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.710 |
Device Problems
Overheating of Device (1437); Intermittent Energy Output (4025)
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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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As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported from (b)(6) that the battery oscillator device would heat up and turn off and then work again.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 but was known to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device control unit did not function, the motor seized, jammed and moved heavily moving.The device also failed pretest for functional test and trigger test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.A review of the service history record indicates that the device had been returned previously for an unrelated malfunction.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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