inforMED
MalfunctionPKL

OVESCO FTRD SYSTEM SET

Received May 23, 2018 · Event occurred May 1, 2018

Report MW5077424 · MDR key 7540403

Device

Generic name

Clipping Device, Hemostatic, Metal Clip

Model number

200.70

Lot number

807554

Product problems

  • Misfire

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING COLONOSCOPY THE CLIP DEPLOYING DEVICE FAILED TO PROPERLY DEPLOY A CLIP, ESSENTIALLY RESULTING IN A MISFIRING OF THE CLIP AS IT WAS STILL ATTACHED TO THE END OF THE DEVICE WHEN THE DEVICE WAS RETRACTED.