The sphincterotome v (kd-vc631q-07301a) device has not been returned to the service center for evaluation as it has been reported to have been discarded by the user facility.Therefore, the exact cause for the guide wire protruding through the tome cannot be determined; if the device is returned, an evaluation will be conducted and a supplemental report will be submitted.
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The service center received a report of five single use sphincterotome v devices (model kd-vc631q-07301a), all from lot number 9yv, that upon insertion of the guidewire, it went through the side of the tome during an unspecified procedure.It was reported that all five devices malfunctioned in the same manner.This is for the fifth kd-vc631q-07301a device reported.It was reported that the intended procedure was completed with a new device and there was no patient injury.The device was discarded upon completion of the procedure and will not be returned to the service center for evaluation.This is report 5 of 5.
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