PENTAX
Received Oct 21, 2024 · Event occurred Oct 11, 2024
Report 9610877-2024-57660 · MDR key 20490495
Device
Generic name
Fiberopticintubationscope 2.6c 5.1tp Rop
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
FI-16RBSProduct problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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) FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LCB (LIGHT CARRYING BUNDLE) FLUID DAMAGE, THE OPERATION CHANNEL (PRIMARY) PERFORATED, 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).