Description of Event or Problem · 0
THE PROVIDER PERFORMED AN UPPER GI ENDOSCOPY WITHOUT DIFFICULTY. AFTER THIS PROCEDURE, THE PROVIDER INITIATED AN ENDOSCOPIC SLEEVE GASTROPLASTY, WHICH WAS TERMINATED PREMATURELY DUE TO BLEEDING AT THE POSTERIOR WALL OF THE BODY OF THE STOMACH. AN ARTERY WAS CLIPPED, AND HEMOSTASIS WAS ACHIEVED. DURING THE ENDOSCOPIC SLEEVE GASTROPLASTY, THE ENDOMINA SUTURING SYSTEM WAS UTILIZED. AS THE GI TECHNICIAN ATTEMPTED TO LOAD A NEW TAPE INTO THE ENDOMINA DEVICE, THE NEEDLE SHEARED THROUGH THE SHEATH AND CLIPPED THE PATIENT'S ARTERY. THE VENDOR REPRESENTATIVE TRAINED THE GI TECHNICIAN ON THE DEVICE THE DAY PRIOR AND INFORMED HIM TO KEEP THE DEVICE STRAIGHT; OTHERWISE, THE NEEDLE COULD GO THROUGH THE SHEATH. ACCORDING TO THE GI TECHNICIAN, THE VENDOR REPRESENTATIVE PROVIDED COACHING THROUGHOUT THE PROCEDURE. THE GI TECHNICIAN ATTEMPTED TO FOLLOW THE VENDOR REPRESENTATIVE'S INSTRUCTIONS. ONCE IT WAS DISCOVERED THAT THE NEEDLE HAD CLIPPED THE PATIENT'S ARTERY, THE PROCEDURE WAS ABORTED. THE VENDOR REPRESENTATIVE HAS THE EQUIPMENT INVOLVED IN THIS INCIDENT, AND AT THIS TIME IT IS UNCLEAR IF THIS INCIDENT IS ATTRIBUTABLE TO OPERATOR ERROR OR AN EQUIPMENT MALFUNCTION. MANUFACTURER RESPONSE FOR ENDOSCOPIC TISSUE APPROXIMATION DEVICE - TAPES, TAPES (PER SITE REPORTER). UNKNOWN.