PENTAX

Additional Manufacturer Narrative

G4: THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NOT DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT ARE LISTED IN USA. 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 SEGMENT FLUID DAMAGE, THE CONTROL BODY FLUID DAMAGE, THE OCULAR FLUID DAMAGE, THE CFB SCREEN COVER GLASS FLUID DAMAGE, THE CFB (COHERENT FIBER BUNDLE) FLUID DAMAGE, THE LCB (LIGHT CARRYING BUNDLE) FLUID DAMAGE, THE OBJECTIVE LENS FLUID DAMAGE, THE OPERATION CHANNEL (PRIMARY) BUCKLED, THE CONTROL BODY CORRODED, THE INSERTION FLEXIBLE TUBE CRUSHED, THE SCREEN MASK DIRTY, AND THE INSERTION FLEXIBLE TUBE TWISTED; 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).