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Recall Observatory FDA recall evidence

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

December 12, 2018

Class II

Product summary

Firm
Applied Medical Resources Corp
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

    reason.no_named_rule · v1.0.0

    Unintentional shifting of the tip insulation of the firm's electrosurgical probes.