It was reported that during setup for a case, the camera will not operate.The case was aborted and the procedure was converted to manual.The evaluation found that the camera cable had a large cut, exposing the wires inside and appeared to have been pinched in several areas along the cable.The nature of the damage indicates that the cable was most likely pinched under heavy equipment (or table or cart) or cut by a sharp object.The cut and pinched areas show that it is likely that there is internal wiring damage along the cable, causing the issues with camera operation.The camera worked fine when it was connected to a known good camera cable confirming the issue was the damaged cable.
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The device was intended for use in treatment and was returned for investigation.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.This is an identified failure mode within the risk assessment.The surgical system user's manual released at the time of the complaint (pn 500097 rev e) provides instructions for checking the proper function and connection of cables.The investigation confirmed there was a relationship established between the reported event and the device.Based on the investigation the returned camera cable had a large cut, exposing the wires inside and appeared to have been pinched in several areas along the cable.The nature of the damage indicates that the cable was most likely pinched under heavy equipment (or table or cart) or cut by a sharp object.When the returned camera was connected to a system using a known good camera cable, there were no issues.When the returned camera cable was connected to a system with a known good camera, the camera did not connect.This further confirms that the issues were with the camera cable and not the camera.The malfunction was due to user error.No containment or corrective actions are recommended at this time.Per complaint details, the device malfunctioned during set-up; however, based on the product evaluation, currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the procedure change/subsequent modified procedure did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time.Additionl information on a1.
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