Device product

SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

Z-1097-2020

January 13, 2020

Class II

Product summary

Firm: Stryker Instruments Div. of Stryker Corporation
Event: Event 84721
Status: Terminated
Classification: Class II
Quantity: 15150
Official record key: device-enforcement:Z-1097-2020

Official wording

Reason: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.

Code information: 1921032

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.