| 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. |
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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
|
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