DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.710 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2019 |
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi ¿ (b)(4).
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Event Description
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It was reported from (b)(6) that the battery oscillator device became very warm and was not working at all.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the battery oscillator device would not run, and the motor was damaged.It was noted that the handpiece had a defect in the motor.It was further determined that the device failed pretest for functional test.Therefore, the reported condition that the device had become very warm was confirmed.The assignable root cause was determined to be due to wear from normal use over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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H10: depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Correction: d10: the date returned to manufacturer was documented as may 22, 2019 on the previous supplemental report.This date has been updated to april 29, 2019.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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