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Model Number 530.710 |
Device Problems
Output below Specifications (3004); Intermittent Energy Output (4025)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper repair by the service center, reprocessing and wear.Udi: ((b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the battery oscillator device oscillation head would stop under load but the motor would run.The connecting point of both parts were worn out and the oscillation head can rotate inside of the adjuster fork.It was also determined that the electrical plugs are also worn out and there is liquid inside of the sliding sleeve.It was noted in the service order that the device had a repeating fault, loses power and it is not possible to cute the bone.The event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.
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Search Alerts/Recalls
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