PENTAX
Received Aug 9, 2024 · Event occurred Jul 26, 2024
Report 9610877-2024-55879 · MDR key 19946679
Device
Generic name
Fiberopticintubationscope 2.6c 5.1tp Rop
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
FI-16RBSProduct problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB (COHERENT FIBER BUNDLE) AS DEFECTIVE. 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 UP RECEPTACLE CRACKED AT ANGLE WIRE SIDE; 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 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).