PENTAX
Received Feb 19, 2026 · Event occurred Feb 9, 2026
Report 9610877-2026-50410 · MDR key 24385329
Device
Generic name
Fiberopticintubationscope 2.4tp Ro Pls
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
FP-7RBS2Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- 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 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 CONTROL BODY FLUID DAMAGE, THE CFB SCREEN COVER GLASS FLUID DAMAGE, THE CFB (COHERENT FIBER BUNDLE) FLUID DAMAGE, AND THE INSERTION FLEXIBLE TUBE PERFORATED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. 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 UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).