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U.S. Department of Health and Human Services

Class 2 Device Recall INVUITY PHOTON BLADE

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  Class 2 Device Recall INVUITY PHOTON BLADE see related information
Date Initiated by Firm June 12, 2017
Create Date July 28, 2017
Recall Status1 Terminated 3 on June 28, 2023
Recall Number Z-2778-2017
Recall Event ID 77607
510(K)Number K162053  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product INVUITY(R) PhotonBlade(TM), REF PB1
Code Information All Lot Numbers
Recalling Firm/
Manufacturer		 Invuity, Inc.
444 De Haro St
San Francisco CA 94107-2347
For Additional Information Contact Steve Annen
415-655-2143
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action Official notices were sent to customers via FedEx overnight on 6/14/17. Email notices were sent to the sales personnel 06/12/2017 regarding the return of their trunk stock inventory and asking them to also contact customers who had been sent letters.
Quantity in Commerce 1328 units
Distribution nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Invuity Inc.
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