inforMED
MalfunctionCAL

PENTAX

Received Sep 5, 2024 · Event occurred Aug 28, 2024

Report 9610877-2024-56733 · MDR key 20142592

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

Additional Manufacturer Narrative

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 INSERTION FLEXIBLE TUBE COATING DAMAGE; HOWEVER, THIS DEFECT IS 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.

Description of Event or Problem

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