FDA Device

Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

Hazard

The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.

What You Should Do

Remedy

Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.

Products

Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Brand
Olympus Corporation of the Americas
UPC
Serial Number 7621683

Units Affected

1