PENTAX
Received Apr 11, 2025 · Event occurred Apr 1, 2025
Report 9610877-2025-51580 · MDR key 21822903
Device
Generic name
Fiberopticintubationscope 2.6c 5.1tp Rop
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
FI-16RBSProduct problems
- Obstruction of Flow
- Obstruction of Flow
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 OPERATION CHANNEL (PRIMARY) BLOCKED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE OPERATION CHANNEL (PRIMARY). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CFB (COHERENT FIBER BUNDLE) BROKEN, THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE INSERTION FLEXIBLE TUBE BUCKLED, AND THE INSERTION FLEXIBLE TUBE CRUSHED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0588(CHANNEL)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.
Description of Event or Problem
THE TIME OF EVENT IS DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Additional Manufacturer Narrative
CORRECTION INFORMATION: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G6: FOLLOW UP #1. H2: IF FOLLOW-UP, WHAT TYPE? CORRECTION. THERE WAS A TYPO IN SOME OF B5: DESCRIBE EVENT OR PROBLEM, WHICH HAS BEEN CORRECTED.
Description of Event or Problem
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.