Device product
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Z-0498-2025
Product summary
- Event
- Event 95600
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1749 units
- Official record key
device-enforcement:Z-0498-2025
Official wording
Reason: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Code information: Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.
Distribution pattern: Domestic: US Nationwide Distribution.
Derived failure modes
-
Unknown
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.