DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 530.710 |
Device Problem
Unexpected Shutdown (4019)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Udi: (b)(4).Reporter's name, phone number and address were not provided.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.
|
|
Event Description
|
It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the battery oscillator device lost power during use.There were no delays in the surgical procedure.It was unknown if a spare device was available for use.The procedure was completed successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
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.The actual device was returned for evaluation.The device was evaluated and no failures were identified.Therefore, the reported condition was not confirmed and assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|