MalfunctionCAL

PENTAX

Received Mar 5, 2025 · Event occurred Feb 20, 2025

Report 9610877-2025-51252 · MDR key 21521674

Device

Generic name

Fiberopticintubationscope 1.2c 3.0tp Rop

Manufacturer

Hoya Corporation Pentax Tokyo Office

Model number

FI-9RBS

Product problems

Loose or Intermittent Connection
Loose or Intermittent Connection

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. BIOPSY INLET PIECE LOOSENED.

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 PIECE LOOSE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE BIOPSY INLET PIECE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE FORWARD BODY COVER BROKEN, THE SIDE BODY COVER BROKEN, THE INSERTION FLEXIBLE TUBE PERFORATED, THE INSERTION FLEXIBLE TUBE CRUSHED, AND THE INSERTION FLEXIBLE TUBE TWISTED; 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-0620(CONTROL BODY)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.