OtherFAT

KARL STORZ

Received Apr 3, 2001 · Event occurred Mar 7, 2001

Report 2020550-2001-00011 · MDR key 324524

Device

Generic name

"jackson" Bougie

Manufacturer

Karl Storz Gmbh & Co.

Model number

10392E

Catalog number

10392E

Lot number

Product problems

Device, or device fragments remain in patient
Tip breakage

Patient

58 YR

Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

DURING THE PROCEDURE, A KARL STORZ "JACKSON" BOUGIE WAS ALLEGEDLY USED. THE PLASTIC TIP OF THE BOUGIE CAME OFF IN THE PT'S STOMACH. THE SURGEON WAS UNABLE TO RETRIEVE THE PIECE AND DECIDED TO LEAVE IT. DOCTOR EXPECTS THAT THE PIECE WILL PASS THROUGH THE PT BY ITSELF.