Brand Name | HARMONIC ACE |
Type of Device | INSTRUMENT, ULTRASONIC SURGICAL |
Manufacturer (Section D) |
ETHICON ENDO-SURGERY, LLC |
4545 creek road |
ml 120a |
cincinnati OH 45242 |
|
MDR Report Key | 6417115 |
MDR Text Key | 70358825 |
Report Number | 6417115 |
Device Sequence Number | 1 |
Product Code |
LFL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
03/01/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 10/31/2021 |
Device Catalogue Number | HARH45 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/01/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/01/2017 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/20/2017 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | NO |
|
|