Catalog Number 72200873 |
Device Problems
Electrical /Electronic Property Problem (1198); Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a knee scope.When a motor drive unit was plugged into the dii controller, it got hot.Surgery was completed after a 5-minute delay using a back-up device instead.The handpiece was later tested in another dii controller and it worked fine.No further complications were reported.
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Manufacturer Narrative
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H10: h3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation revealed a short circuit detected message in port a.Further evaluation revealed a burnt resistor.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with a defective electronic component.Factors which can contribute to component failure are connecting a hand piece that is still wet from sterilization processing or connecting a shorted out hand piece causing damage to the motor controller pcb.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that, during a knee scope.When ta motor drive unit was plugged into the dii controller, the dii controller was causing the handpiece became hot.Surgery was completed after a 5-minute delay using a back-up device instead.The handpiece was later tested in another dii controller and it worked fine.No further complications were reported.
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Search Alerts/Recalls
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