Skip to content
Recall Observatory FDA recall evidence

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

June 17, 2015

Class II

Product summary

Firm
ConMed Corporation
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

    reason.device_software_design · v1.0.0

    programming error