PENTAX
Received Sep 24, 2024 · Event occurred Sep 10, 2024
Report 9610877-2024-56913 · MDR key 20289372
Device
Generic name
Fiberopticintubationscope 2.4tp Ro Pls
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
FI-7RBSProduct problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
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 UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ANGLE WIRE CUT.
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 ANGLE WIRE RUPTURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE ANGLE WIRE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LCB (LIGHT CARRYING BUNDLE) BROKEN, AND THE INSERTION FLEXIBLE TUBE COMPRESSED (SHORT IN LENGTH); HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. IN TERMS OF THE ANGLE WIRE RUPTURE, THE POSSIBILITY OF ANGULATION STUCK OCCURRED IN THE HUMAN BODY COULD NOT BE DENIED. MOREOVER, BASED ON THE TECHNICAL REPORT""HR-RPT-0587(ANGLE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.