PENTAX
Received Jul 4, 2022 · Event occurred Jun 7, 2022
Report 9610877-2022-55315 · MDR key 14903328
Device
Generic name
Video Sigmoidoscope 4.2c 12.8t 700l Fwj
Manufacturer
Hoya Corporation Pentax Tokyo OfficeModel number
ES-3870KProduct problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
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. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).
Additional Manufacturer Narrative
WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE NOZZLE GLUING MISSING. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE PHYSICAL DAMAGE APPLIED ON THE NOZZLE GLUING. IN ADDITION, WE CONFIRMED THAT THE SERIAL NUMBER PLATE MISSING, AND THE BENDING RUBBER GLUING POOR FINISH; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. AS A RESULT OF CONFIRMING THE DETAIL AS GFE, NO RESPONSE WAS OBTAINED, SO WE CAN NOT DENY THE POSSIBILITY OF THE GLUE FALLS. THEREFORE, BASED ON THE TECHNICAL REPORT "HR-RPT-0585(NOZZLE)" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.