FUJINON
Received Apr 11, 2017 · Event occurred Jan 6, 2017
Report 6479948 · MDR key 6479948
Device
Generic name
Endoscope, Fiber Optic
Manufacturer
Fujifilm Medical Systems U.s.a., Inc.Model number
EN-450T5Product problems
- Break
Patient
87 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PROCEDURE: ESOPHAGOGASTRODUODENOSCOPY WITH DOUBLE BALLOON ENTEROSCOPY NN: FUJINON DOUBLE BALLOON SCOPE BROKE DURING THE PROCEDURE. WE CHANGED TO A SECOND SCOPE. THE BROKEN SCOPE WAS IMMEDIATELY SENT OUT FOR REPAIR PER OUR PROTOCOL. THE DOUBLE BALLOON ENTEROSCOPY PROCEDURE HAS A POTENTIAL FOR GASTRIC MUCOSAL INJURY BECAUSE OF THE DISTANCE THE SCOPE TRAVELS INTO THE SMALL INTESTINE AND THE POTENTIAL FOR SUBSEQUENT LOOPING IN THE STOMACH. THE SCOPE DIALS BREAKING DIDN'T CAUSE THE MUCOSAL INJURY. CORRECT ENDOSCOPE FUJINON INC. MEDICAL DIVISION COLONOSCOPE DOUBLE BALLOON ENDOSCOPY MODEL EN-450T5.