Olympus Corporation of the Americas: 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.

Agency Publication Date: March 12, 2019

Affected Products

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

Serial Number 7621683

Product: Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

Serial Number 2418319

Product: Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

Serial Number 2501374 and 2704914

Product: Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

Serial Number 2506043 and 2619818

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82099

Status: Resolved

Manufacturer: Olympus Corporation of the Americas

Manufactured In: United States

Units Affected: 4 products (1; 1; 2; 2)

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Sources: FDA iRES · Raw API Response

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