inforMED
MalfunctionMND

ENDOLOOP

Received Jul 23, 2024 · Event occurred Jun 10, 2024

Report 19804858 · MDR key 19804858

Device

Generic name

Ligator, Esophageal

Model number

HX-400U-30

Lot number

39V

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

EVENT 1: "USING OLYMPUS ENDOLOOP FOR POLYPECTOMY. DEVICE FAILED TO DEPLOY PROPERLY AND BECAME STUCK IN THE PATIENT. CUTTING THE HANDLE/ INTERNAL WIRE DID NOT RELEASE AS PER RECOMMENDATION OF TECHNICAL SUPPORT. DIFFICULTY REMOVING SCOPE OVER THE FAILED DEVICE FOR FEAR OF RIPPING OFF POLYP. EVENTUALLY USED SCISSOR TOOL THROUGH A DIFFERENT SCOPE AND CUT THE DEVICE OFF SAFELY.". EVENT 2: "ANOTHER ENDOLOOP FAILED TO DEPLOY PROPERLY TODAY. (DR [REDACTED NAME] WAS WARNED ABOUT MONDAY'S INCIDENT BUT WANTED TO PROCEED WITH ENDOSCOPY.) AS HE WAS TIGHTENING LOOP AROUND THE GASTRIC POLYP, THE HANDLE BROKE. FORTUNATELY, IT WAS NOT TIGHT, AND HE WAS ABLE TO DEFLECT IT OFF THE POLYP. ALL PRODUCT WAS REMOVED FROM SHELF AND WILL BE RETURNED FOR CREDIT.".