Device product
Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
Z-0205-2016
Product summary
- Event
- Event 71518
- Status
- Terminated
- Classification
- Class II
- Quantity
- 276 devices
- Official record key
device-enforcement:Z-0205-2016
Official wording
Reason: Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
Code information: 1412161, 1410201, 1410271, 1412121, and 1412081
Distribution pattern: Worldwide - US distribution in the states of FL, OH, and the country of Spain.
Derived failure modes
-
Device software or design
programming error