MalfunctionKNS

SINGLE USE PRELOADED SPHINCTEROTOME V

Received Jul 9, 2026 · Event occurred Jun 10, 2026

Report MW5190561 · MDR key 25767515

Device

Generic name

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Manufacturer

Olympus Medical Systems Corp.

Patient

25 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DEVICE (SINGLE USE PRELOADED SPHINCTEROTOME V) UTILIZED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, NOT WORKING PROPERLY. DEVICE INSERTED THROUGH SCOPE DEFECTIVE. WHEN TECH TRIED TO USE DEVICE WAS KINKED AT THE TIP. DEVICE WAS PULLED OUT OF SCOPE AND NEW DEVICE HAD TO BE UTILIZED. NO PATIENT HARM NOTED.