PENTAX

Description of Event or Problem

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

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 OCULAR FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE OCULAR. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CFB (COHERENT FIBER BUNDLE) FLUID DAMAGE, THE U/D KNOB BROKEN, THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE CONTROL BODY CORRODED, THE FORWARD BODY FRAME CORRODED, AND THE INSERTION FLEXIBLE TUBE CRUSHED; 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.