COUPLER, ZOOM, HD, C-MOUNT

Additional Manufacturer Narrative

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT UPON INSPECTION OF THE C-MOUNT ZOOM COUPLER, AR-3210-0006, IT HAD CLEAR VISIBLE DAMAGE AND THE COUPLER DID NOT SCREW INTO THE SCOPE PROPERLY. THE BROKEN COUPLER WAS TAGGED FOR ISOLATION AND, IN THIS INSTANCE, IT WAS NOT USED. UNFORTUNATELY IT WAS PUT BACK INTO SERVICE AND THE NEXT SURGEON OPERATED USING THE DAMAGED COUPLER. DURING A CYSTOSCOPY PROCEDURE, THE C-MOUNT ZOOM COUPLER, AR-3210-0006, WAS USED AND PIERCED THE PATIENT'S BLADDER WALL LEADING TO AN OVERNIGHT STAY IN THE HOSPITAL TO MONITOR PATIENTS CONDITION. NO FURTHER DETAILS PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 5/1/2019: THE ZOOM OPTICAL C-MOUNT COUPLER WAS NOT ABLE TO SCREW IN PROPERLY TO THE C-MOUNT CAMERA. DURING THE OPERATION THE COUPLER DISENGAGED FROM THE CAMERA AND THE SCOPE INADVERTENTLY PIERCED THE PATIENTS BLADDER WALL. THE SCOPE USED WAS NOT AN ARTHREX SCOPE. AT THIS STAGE THE PRIMARY OBJECTIVE OF THE CYSTOSCOPY WAS ALREADY COMPLETED AND THE SURGEON WAS HAPPY TO END THE CASE. THE PATIENT WAS ADMITTED OVERNIGHT POST SURGERY FOR OBSERVATION PURPOSES. NO SUBSEQUENT ISSUES WERE REPORTED AND THEY WHERE ALLOWED TO GO HOME THE FOLLOWING MORNING.

Additional Manufacturer Narrative

THE EVALUATION CONFIRMED THE DAMAGE TO THE DEVICE. CONSEQUENTLY, THE DEVICE WAS NOT ABLE TO ADEQUATELY SECURE THE TEST SCOPE. THE CAUSE WAS ATTRIBUTED TO MISHANDLING/MISUSE.