MalfunctionCAL

PENTAX

Received Nov 28, 2024 · Event occurred Nov 18, 2024

Report 9610877-2024-58600 · MDR key 20803537

Device

Generic name

Fiberopticintubationscope 1.4c 3.4tp Rop

Manufacturer

Hoya Corporation Pentax Tokyo Office

Model number

FI-10RBS

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. SUCTION NIPPLE 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 SUCTION ARM LOOSE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE SUCTION ARM. 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.