PENTAX MEDICAL
Received May 18, 2026 · Event occurred Apr 30, 2026
Report 9610877-2026-51086 · MDR key 25197191
Device
Generic name
Video Naso Pharyngo Laryngoscope
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
VNL11-J10Product problems
- No Display/Image
Patient
NA · Unknown
- 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 BLACKOUT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LG CONNECTOR FLUID DAMAGE, THE REMOTE CONTROL BUTTONS CRACKED, THE SHIELD COVER CORRODED, AND THE REMOTE CONTROL BUTTONS LEAK; 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.
Description of Event or Problem
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).