DEPUY SYNTHES PRODUCTS LLC BATTERY RECIPROCATOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.615 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/28/2018 |
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 reciprocator device lacked strength and became hot.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 injuries, medical intervention or prolonged hospitalization.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.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the motor sounded weak and the voltage dropped and had high amperage.It was further reported that the device had corroded components.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due normal wear and improper maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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