MalfunctionFAM
PENTAX
Received Oct 28, 2024 · Event occurred Oct 7, 2024
Report 9610877-2024-57838 · MDR key 20542162
Device
Generic name
Video Sigmoidoscope 4.2c 12.8t 700l Fwj
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
ES-3870KProduct problems
- Erratic or Intermittent Display
- Erratic or Intermittent Display
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 CCD MODULE WITH DRIVE PCB DISTORTED IMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE WITH DRIVE PCB. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586(IMAGE FAILURE)"" 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. VIDEO IMAGE FAILURE.