MalfunctionFDS

GASTROSCOPE

Received Mar 27, 1998 · Event occurred Mar 16, 1998

Report MW1013386 · MDR key 159997

Device

Generic name

Gastroscope

Manufacturer

Model number

Catalog number

Lot number

Description of Event or Problem

THERE HAS BEEN AN INCREASING OCCURRENCE OF "PEELING" OF THE OUTER SHEATH ON THE INSERTION TUBE OF THESE ENDOSCOPES.