PENTAX

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB (COHERENT FIBER BUNDLE) BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CONTROL BODY FLUID DAMAGE, THE FORWARD BODY FRAME FLUID DAMAGE, THE BIOPSY INLET T-PIECE FLUID DAMAGE, THE LIGHT SOURCE CONNECTOR FLUID DAMAGE, THE OCULAR FLUID DAMAGE, THE CFB SCREEN COVER GLASS FLUID DAMAGE, THE CFB (COHERENT FIBER BUNDLE) FLUID DAMAGE, THE SIDE BODY COVER BROKEN, THE INSERTION FLEXIBLE TUBE PERFORATED, THE INSERTION FLEXIBLE TUBE BUCKLED, AND THE OPERATION CHANNEL (PRIMARY) RESISTANCE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586(IMAGE FAILURE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

Description of Event or Problem

THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).