Device product
Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.
Z-1943-2018
Product summary
- Firm
- Olsen Medical
- Event
- Event 80080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71,890 devices
- Official record key
device-enforcement:Z-1943-2018
Official wording
Reason: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Code information: all codes
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Labeling or packaging
pouch seal thereby increasing the risk of the seal being compromised
-
Sterility assurance
sterile pouch seal thereby increasing the risk of the seal being compromised