inforMED
MalfunctionCAL

PENTAX

Received Apr 11, 2025 · Event occurred Apr 1, 2025

Report 9610877-2025-51581 · MDR key 21822902

Device

Generic name

Fiberopticintubationscope 2.4tp Ro Pls

Model number

FP-7RBS2

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 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 SIDE BODY COVER BROKEN, AND THE INSERTION FLEXIBLE TUBE CRUSHED; 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.

Additional Manufacturer Narrative

CORRECTION INFORMATION: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM G6: FOLLOW UP #1 H2:IF FOLLOW-UP, WHAT TYPE? THERE WAS A TYPO IN SOME OF B5: DESCRIBE EVENT OR PROBLEM, WHICH HAS BEEN CORRECTED.

Description of Event or Problem

THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).