inforMED
MalfunctionCAL

PENTAX

Received May 7, 2025 · Event occurred Apr 23, 2025

Report 9610877-2025-51823 · MDR key 21973938

Device

Generic name

Fiberopticintubationscope 2.6c 5.1tp Rop

Model number

FI-16RBS

Product 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 BIOPSY INLET T-PIECE CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE BIOPSY INLET T-PIECE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CFB (COHERENT FIBER BUNDLE) BROKEN, AND THE INSERTION FLEXIBLE TUBE PERFORATED; 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-0588(CHANNEL)"" 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. OPERATION/SUCTION CHANNEL CLOGGED.