Catalog Number 530.630 |
Device Problems
Mechanical Problem (1384); No Device Output (1435)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device manufacture date: the device manufacture date is unavailable.(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the battery device ran out of power after it was fully charged.During service and evaluation it was found that the battery device was generally worn out.It was not reported if there were any delays in the procedure due to the event.It was reported that there was an unspecified spare battery available and the handpiece ran correctly.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.The exact date of this event was unknown.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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Additional narrative: (b)(4).The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).Contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.The previous report stated the date of manufacture (dom) was unknown.The dom (jan 27, 2016) has been updated to reflect the date the device was manufactured.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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