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Model Number 72200873 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2021 |
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 no issue was observed.A functional evaluation revealed a hand piece sensor fault.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 a shorted component on the pcb or a defective port harness.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that the dii controller was not working properly.The incident occurred during an inspection; therefore, there was no patient involvement.No delay reported.Results of investigation have concluded that this unit had a handpiece sensor fault 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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