Device product
Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Z-1099-2020
Product summary
- Event
- Event 84721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15150
- Official record key
device-enforcement:Z-1099-2020
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: 1922042, 1924003, 1929040, 1929048
Distribution pattern: Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Derived failure modes
-
Unknown
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.