FDA Adverse Event Injury Summary report: N

PENTAX DUODENOSCOPE

MDR report key: 21834314 · Received April 14, 2025

Report

Report Number
MW5168991
Event Type
Injury
Date Received
April 14, 2025
Date of Event
April 1, 2025
Report Date
April 8, 2025
Manufacturer
PENTAX/ HOYA CORPORATION PENTAX LIFECARE DIVISION
Product Code
FDT
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2270323 PENTAX DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT PENTAX/ HOYA CORPORATION PENTAX LIFECARE DIVISION ED 34I10 T2

Patients

Seq Age Sex Outcome Treatment
1 67 YR Female Required Intervention ALLEGRA.| AUGMENTIN.| BUSPAR.| CLEOCIN.| COZAAR.| ESTRACE.| HYDRODIURIL.| LIPITOR.| LOPRESSOR.| NORCO.| PRILOSEC.| RIFADIN.| SINGULAIR.| VENTOLIN HFA.| ZOFRAN.| ZYRTEC.