inforMED
MalfunctionCAL

PENTAX

Received Jan 17, 2025 · Event occurred Jan 9, 2025

Report 9610877-2025-50274 · MDR key 21175921

Device

Generic name

Fiberopticintubationscope 1.8c 4.1tp Rop

Model number

FI-13RBS

Product problems

  • Break
  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).

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) BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE INSERTION FLEXIBLE TUBE BITE DAMAGE, AND THE OPERATION CHANNEL (PRIMARY) LEAK; 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.