It was reported that during a knee scope procedure, controller prong was broken.A backup device was available to complete the procedure.However, a delay greater than 30 minutes was reported.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and found both mdu ports were damaged.Product could not be functionally tested due to the damaged mdu ports.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force, misalignment, or twisting of the connector during connection/disconnection to the control unit receptacle.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 found related failures; this failure mode will be trended to assess for any necessary corrective actions.No containment or corrective actions are recommended at this time.
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