SYNTHES OBERDORF SMALL BATTERY DRIVE 14.4 VOLT LITHIUM ION; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.103 |
Device Problems
Failure to Charge (1085); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Initial reporter's phone number: (b)(6).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.
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Event Description
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This is report 3 of 9 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the battery devices gave an error signal and did not charge anymore when used with the universal battery charger devices.According to the reporter, there were six battery devices used with three universal battery charger devices.It was reported that there was a delay in surgery; however the duration time was not specified.Spare devices were available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device.The external features of the device were visually inspected and it was determined that there was no evidence of abuse or manufacture issues.The device was tested and it was confirmed that the device was damaged.It was determined that the device had a blown fuse.Therefore, the reported condition was confirmed.It was determined that the root cause of the battery failure was due to excessive current that caused the battery to blow the fuse, suggesting that the battery had been connected to a device that had a short circuit.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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During subsequent follow-up with the reporter, it was clarified that there was approximately thirteen to fifteen minutes delay in the surgical procedure.Correction: it was further reported that after surgery, the defective battery devices were tested on all three battery chargers as a confirmation of the battery defectiveness.The mention of the battery chargers displaying the red light on the chargers was in reference to the outcome of testing the battery devices.The reporter stated that there was not alleged malfunction against the battery charger devices.Therefore, the event numbering represented in the initial report has been updated from ¿report 3 of 9 for the same event¿ to ¿report 3 of 6 for the same event.¿ 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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