inforMED
InjuryFDT

PENTAX DUODENOSCOPE

Received Apr 14, 2025 · Event occurred Apr 1, 2025

Report MW5168991 · MDR key 21834314

Device

Generic name

Duodenoscope And Accessories, Flexible/rigid

Model number

ED 34I10 T2

Product problems

  • Display or Visual Feedback Problem
  • Patient Device Interaction Problem

Patient

67 YR · Female

  • Internal Organ Perforation
  • Internal Organ Perforation

Narrative

Description of Event or Problem

THE PATIENT WAS IN THE GI LAB FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PASS A SNARE THROUGH THE PENTAX SCOPE ((B)(6), MODEL ED 34I10 T2). THE SNARE WENT STRAIGHT INTO THE ANTRUM AND POSSIBLY THROUGH THE STOMACH DUE TO THE SCOPE ELEVATOR NOT WORKING PROPERLY. THE PHYSICIAN PLACED 3 CLIPS TO CLOSE THE AREA AND ORDERED A STAT KUB AND COMPUTED TOMOGRAPHY (CT). THE PATIENT REPORTED MINIMAL DISCOMFORT UPON WAKING UP FROM ANESTHESIA AND WAS ABLE TO BE DISCHARGED AFTER THE IMAGING WAS COMPLETED AND REVIEWED. THE ABDOMEN AND PELVIS COMPUTED TOMOGRAPHY (CT) REVEALED NO EVIDENCE OF FREE AIR OR DRAINABLE FLUID COLLECTION. THE X-RAY KUB IMPRESSION WAS NONSPECIFIC BUT WITHOUT EVIDENCE OF OBSTRUCTION, AND NO DEFINITE LARGE COLLECTION OF FREE AIR WAS DEMONSTRATED. THIS SCOPE HAD BEEN RETURNED FROM THE PENTAX SERVICE DEPARTMENT A FEW DAYS AGO AFTER HAVING BEEN SENT FOR REPAIR OF DECREASED ELEVATOR ANGULATION. FOLLOWING THIS EVENT, THE SCOPE HAS BEEN REMOVED FROM SERVICE.