PENTAX
Received May 23, 2024 · Event occurred May 16, 2024
Report 9610877-2024-53808 · MDR key 19379277
Device
Generic name
Video Sigmoidoscope 4.2c 12.8t 700l Fwj
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
EC-3870FK2Product problems
- Obstruction of Flow
- Obstruction of Flow
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 OPERATION CHANNEL (PRIMARY) STUCK ACCESSORY/OBJECT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE OPERATION CHANNEL (PRIMARY). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE BENDING RUBBER CUT, THE LCB DISTAL COVER GLASS DIRTY, THE AIR NOZZLE LOOSE, AND THE LCB (LIGHT CARRYING BUNDLE) DEFECTIVE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0588(CHANNEL)"" 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. OPERATION/SUCTION CHANNEL CLOGGED.