inforMED
MalfunctionPKL

OTSC SYSTEM SET

Received Oct 5, 2023 · Event occurred Sep 29, 2023

Report MW5146661 · MDR key 17886433

Device

Generic name

Hemostatic Metal Clip For The Gi Tract

Patient

60 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE CLIP WOULD NOT DEPLOY IN THE SCOPE, THE DOCTOR CONTINUED TO CRANK ON THE CLIP WHICH CAUSED INTERNAL DAMAGE TO THE SCOPE. THERE WAS NO INJURY TO THE PATIENT. SCOPE WAS REMOVED, CLEANED, AND SENT OUT FOR REPAIR. ANOTHER SCOPE WAS USED WITH ANOTHER CLIP TO COMPLETE THE PROCEDURE.