MalfunctionGEE
N/A
Received Oct 13, 2021 · Event occurred Sep 28, 2021
Report 12623187 · MDR key 12623187
Device
Generic name
Brush, Biopsy, General Plastic Surgery
Manufacturer
Conmed CorporationModel number
000150Catalog number
000150
Lot number
202106164
Product problems
- Material Deformation
Patient
24455 DA
- Perforation
- Perforation
Narrative
Description of Event or Problem
ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED. PATIENT WAS DILATED WITH A 48 FRENCH SAVORY. SURGEON REPORTED PERFORATION WHEN REASSESSING ESOPHAGUS. PROCEDURES WAS ABORTED. IT WAS FOUND THAT THE CLEANGUIDE¿ DISPOSABLE OTW ESOPHAGEAL DILATORS AND MARKED SPRING TIP GUIDEWIRE KINKED DURING THE REMOVAL.