ENDO GIA

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OPERATION CHANNEL (PRIMARY) STUCK ACCESSORY/OBJECT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE OPERATION CHANNEL (PRIMARY). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LIGHT GUIDE CABLE COATING DAMAGE, THE INSERTION FLEXIBLE TUBE BUCKLED, THE ANGLE WIRE PLAY, AND THE INSERTION FLEXIBLE TUBE WORN OUT; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT /OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC COMPLETE STOMACH RESECTION FOR CANCER, WHILE ON ANASTOMOSIS, THERE WAS INCORRECT B STAPLE FORMATION IN ALL 12 RELOADS THAT WERE USED; SOME WERE NOT PROPERLY FORMED, AND SOME STAPLES WERE OPENED. THIS CAUSES THE PATIENT TO HAVE TISSUE BLEEDING AND EVEN SPILL BOWEL CONTENTS INTO THE ABDOMINAL CAVITY. THE STAPLE LINE WAS INCOMPLETE DISTALLY AND HAD TO BE REINFORCED WITH A SUTURE TO FIX THE STAPLE LINE AND RESOLVE THE ISSUE. IT WAS NOTED THAT THE STAPLES THAT FELL OFF IN THE CAVITY AND THAT WERE LEFT OPEN WERE REMOVED.