PENTAX
Received Jul 16, 2024 · Event occurred Jun 21, 2024
Report 9610877-2024-55378 · MDR key 19747616
Device
Generic name
Video Sigmoidoscope 4.2c 12.8t 700l Fwj
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
ES-3870KProduct 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
THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE AIR TUBE CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE AIR TUBE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CCD MODULE WITH DRIVE PCB DISTORTED IMAGE; HOWEVER, THIS DEFECT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT "HR-RPT-0630 (AIR/WATER & JET WATER CHANNELS)" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.
Description of Event or Problem
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.