PENTAX
Received Jun 29, 2023 · Event occurred Jun 14, 2023
Report 9610877-2023-55849 · MDR key 17223158
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
THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN 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, OUR TECHNICIAN CONFIRMED THAT THE CONTROL BODY CRACKED, THE CONTROL BODY LEAK, AND THE BENDING RUBBER GLUING POOR FINISH; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. IN TERMS OF THE GLUE MISSING, THE POSSIBILITY OF DROPPING INTO HUMAN BODY COULD NOT BE DENIED. MOREOVER, BASED ON THE TECHNICAL REPORT""HR-RPT-0585(NOZZLE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.