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Model Number 72200873 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and observed no issues.A functional evaluation revealed a hand piece stall error message.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include connecting a hand piece that is still wet from sterilization processing or connecting a shorted out hand piece causing damage to the main board.The dyonics power ii control system operations/service manual states: to prevent damage to the control unit connector ports, do not plug in wet.Ensure that cleaned or sterilized cable connectors are completely dry prior to connecting to the control unit.
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Event Description
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It was reported that, when dll controller was plugged, it was not working and did not do anything.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit had a blade stall which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Search Alerts/Recalls
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