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 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 INSERTION FLEXIBLE TUBE FLUID DAMAGE, THE CONTROL BODY FLUID DAMAGE, THE FORWARD BODY FRAME FLUID DAMAGE, THE FORWARD BODY COVER FLUID DAMAGE, THE BODY COVER GRIP FLUID DAMAGE, THE SIDE BODY COVER FLUID DAMAGE, THE BIOPSY INLET BARREL FLUID DAMAGE, THE BIOPSY INLET PIECE FLUID DAMAGE, THE BIOPSY INLET T-PIECE FLUID DAMAGE, THE LIGHT SOURCE CONNECTOR FLUID DAMAGE, THE CFB SCREEN COVER GLASS FLUID DAMAGE, THE OCULAR TRIM RING FLUID DAMAGE, AND THE INSERTION FLEXIBLE TUBE BUCKLED; 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(FLUID DAMAGE).