Device product
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Z-0672-2018
Product summary
- Event
- Event 79246
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148.913
- Official record key
device-enforcement:Z-0672-2018
Official wording
Reason: There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
Code information: CCS25, CCS29
Distribution pattern: China
Derived failure modes
-
Unknown
There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.