MalfunctionFDS
PENTAX ENDOSCOPE EG 2990I
Received Aug 14, 2024 · Event occurred Aug 6, 2024
Report MW5158441 · MDR key 19994264
Device
Generic name
Gastroscope And Accessories, Flexible/rigid
Manufacturer
Hoya Corporation Pentax Lifecare DivisionModel number
EG 2990IPatient
1 MO · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
UPON REMOVAL OF ENDOSCOPE AND POST FLUSHING WITH A CLEAR FLUID, PARTICLES RESEMBLING BLACK PLASTIC WAS OBSERVED IN THE CONTAINER HOLDING THE FLUID.