The root cause cannot be determined with the available information.The device is a reusable instrument and was manufactured in 2019; therefore, it is unknown how many times the device was used prior to this reported complaint event nor under what circumstances it was used.The device was tested upon manufacture and met all specifications.The sro work order diagnosis and possible root cause was determined to be "unit is difficult to insert and remove from the console due to damaged cable connector.Motor unit is continuously running due to a malfunction flex circuit in the cable assembly".Review of the complaint database revealed nine (9) reported complaints in the last two (2) years for this issue (one of which is the complaint in this report.Based on the information received and the investigation performed, the root cause could not be determined.
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A service request for the device was received with no product complaint made.On 12 december 2023, the service request work order device diagnosis was completed.During the service request work order, it was noted "unit is difficult to insert and remove from the console due to damaged cable connector.Motor unit is continuously running due to a malfunction flex circuit in the cable assembly ".As a result of these findings of the service request work order, this report is being submitted.Additionally, as a result of the service request work order, the customer was contacted to determine if any surgery or patient was impacted.The customer responded that this issue was noted in their warehouse prior to any surgery with no patient, user, or surgery involved.
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