Catalog Number 532.010 |
Device Problem
Failure to Run on Battery (1466)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2014 |
Event Type
malfunction
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Event Description
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Facility reporter advised the 532.010 (small battery drive) stopped working during a surgery.No further information was provided.Update: the reported event happened during triple plateau leveling osteotomy, there was a 2 minutes delay due to reported event, and a spare device was used to complete the procedure.The procedure was completed successfully without any medical intervention.This is report (1) of (1) for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Subject device has been received and is currently in the evaluation process.Investigation is on going; no conclusion could be drawn.Device is an instrument and is not implanted/explanted.Device was used in veterinary case, patient information will not be provided.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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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Service history of the past six months from the awareness date was reviewed.No service history review can be performed.The item has not been in for service for the past six months.There is no information relevant to the current complained issue.The customer's complaint that the ((b)(4)) small battery drive does not function was confirmed.The unit was tested and did not run when power was applied.Evidence indicates this is due to usage wear over time.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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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional narrative: surgical procedure - cruciate repair.Not previously reported.Quantity: one power device.Not previously reported.The device is an instrument, not implanted/explanted.Not previously reported.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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On 9/10/2014 update - additional information was provide by faxed facility signed questionnaire received on (b)(4) 2014.The small animal surgery supervisor reported: the event took place on (b)(6) 2014 while the surgeon was performing cruciate repair on an unknown species.This reported event is for 1 device.
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Search Alerts/Recalls
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