It was reported that during a shoulder arthroscopy procedure, the dii controller gave a warning message of "short circuit error" and a burning smell, the device overheated.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No further complications were reported.
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Internal complaint reference case (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event a visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation revealed a short circuit detected error message upon plugging unit in.Further evaluation revealed a burnt resistor.No burning smell was noted during testing.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed, and the root cause was 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 motor controller pcb.Please refer to the dyonics power ii control system operations/service manual for recommendations on proper cleaning and sterilization processes.No containment or corrective actions are recommended at this time.
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