Device product
INVUITY(R) PhotonBlade(TM), REF PB1
Z-2778-2017
Product summary
- Firm
- Invuity, Inc.
- Event
- Event 77607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1328 units
- Official record key
device-enforcement:Z-2778-2017
Official wording
Reason: A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
Code information: All Lot Numbers
Distribution pattern: nationwide
Derived failure modes
-
Unknown
A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.