PENTAX
Received Jul 16, 2024 · Event occurred Jun 21, 2024
Report 9610877-2024-55379 · MDR key 19747617
Device
Generic name
Video Sigmoidoscope 4.2c 12.8t 700l Fwj
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
ES-3870KProduct problems
- Fluid/Blood Leak
- Fluid/Blood Leak
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. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE WITH DRIVE PCB FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LG CONNECTOR CORRODED, THE SIDE BODY COVER LEAK, AND THE NOZZLE GLUING DISCOLORED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT "HR-RPT-0586 (IMAGE FAILURE)" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.