MalfunctionGDO
CLIP APPLICATOR, 10 X 330 MM, FOR CLIPS
Received Jan 30, 2019 · Event occurred Dec 10, 2018
Report 8010257-2019-00001 · MDR key 8288103
Device
Generic name
Clip Applicator
Manufacturer
Hermann Medizintechnik GmbhModel number
H30-135-883ELot number
60234
Product problems
- Device Handling Problem
- Device Handling Problem
Patient
Not reported
- Perforation of Vessels
- Perforation of Vessels
Narrative
Description of Event or Problem
THE USER REPORTED THAT WHILE USING CLIP APPLICATOR, THERE WAS AN INCIDENT OF A BLOOD VESSEL BEING CUT WHILE TRYING TO APPLY A CLIP. ANOTHER INCIDENT HAPPENED WHEN CYSTIC DUCT WAS CUT.