Device product
Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.
Z-0509-2020
Product summary
- Event
- Event 83909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 units Domestically - 112 units Internationally
- Official record key
device-enforcement:Z-0509-2020
Official wording
Reason: Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Code information: Model Number: CW002 Lot Numbers: 1336418 and 1340803 Model # Lot # UDI Code CW002 1336418 (01)00607915136147(17)210912(30)01(10)1336418 CW002 1340206 (01)00607915136147(17)211029(30)01(10)1340206 TA211 1340118 (01)20607915139050(17)210812(30)01(10)1340118 TA211 1342169 (01)20607915139050(17)210812(30)01(10)1342169
Distribution pattern: Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Derived failure modes
-
Unknown
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.