Device product
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
Z-2355-2021
Product summary
- Event
- Event 88434
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7870 units
- Official record key
device-enforcement:Z-2355-2021
Official wording
Reason: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Code information: Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.
Derived failure modes
-
Unknown
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns