Device product
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Z-2048-2018
Product summary
- Event
- Event 80066
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25657
- Official record key
device-enforcement:Z-2048-2018
Official wording
Reason: The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Code information: P9125C, P93T5J, P93T5K, P93V06, P93W4Y, P93Y4A, P93W8A, P9400F, P9409V, P94A93, P94A94, P94C8R, P94G1W, P91F4A, P91F86, P93M3W, P93W0A, P93Z4X, P93Z96, P94E6U, P94H32, P94H9V, P94J28
Distribution pattern: Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.
Derived failure modes
-
Unknown
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.