Device product
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
Z-1957-2019
Product summary
- Event
- Event 82946
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 boxes (5 electrodes each)
- Official record key
device-enforcement:Z-1957-2019
Official wording
Reason: E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Code information: Product Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024
Distribution pattern: US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.
Derived failure modes
-
Unknown
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.