CUTTING LOOP, BIPOLAR 24/26FR LOGITUDINL

Additional Manufacturer Narrative

THE DEVICE WILL NOT RETURN TO THE MANUFACTURING SITE FOR INVESTIGATION DUE TO THE FACILITY CANNOT FIND THE CUTTING LOOP. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DR. (B)(6) WHO ARE ONE OF OUR OR DOCTORS, NOTED THE METAL CUTTING LOOP - OF THE STORZ BIPOLAR LONGITUDINAL CUTTING LOOP, DIAMETER 0.30MM 24/26 FR LOT:37LD8996, EXP 2030-01-03, BECAME LOST DURING SURGERY. DR (B)(6) WAS UNABLE TO LOCATE THE MISSING PIECE THUS SHE ORDERED A STAT PORTABLE X-RAY OF PELVIS, INTRA-OP XRAY PERFORMED, PER RADIOLOGIST, X-RAY CONFIRMS THERE IS NO RETAINED OBJECT IN PATIENT. THIS WAS BEING USED WITH THE LARGE RESECTOSCOPE AND THE CUTTING LOOP COMPLETELY DETACHED FROM BOTH SIDES DURING THE PROCEDURE WHILE SIMPLY USING THE SCOPE TO OBSERVE THE UTERINE CAVITY AND NOT APPLYING ANY PULLING/PUSHING OR CAUTERY TO THE LOOP. THIS WAS RECOGNIZED PROMPTLY, AND THE INSTRUMENT WAS REMOVED. A THOROUGH SEARCH OF THE PATIENT/DRAPES/VAGINA/TUBING/FLUID MANAGEMENT WAS PERFORMED, AND THE LOOP WAS NOT IDENTIFIED.