PENTAX
Received Jan 8, 2025 · Event occurred Dec 16, 2024
Report 9610877-2025-50061 · MDR key 21099004
Device
Generic name
Fiberopticintubationscope 2.6c 5.1tp Rop
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
FI-16RBSProduct 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
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 BIOPSY INLET PIECE LOOSE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE BIOPSY INLET PIECE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE FORWARD BODY COVER BROKEN, THE CFB (COHERENT FIBER BUNDLE) BROKEN, THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE OPERATION CHANNEL (PRIMARY) BUCKLED, THE INSERTION FLEXIBLE TUBE BUCKLED, AND THE SEGMENT CRUSHED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. 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.
Description of Event or Problem
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.