Brand Name | MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS |
Type of Device | MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS |
Manufacturer (Section D) |
GYRUS ACMI, INC |
136 turnpike road |
southborough MA 01772 |
|
Manufacturer Contact |
connie
tubera
|
2400 ringwood avenue |
san jose, CA 95131
|
408935-512
|
|
MDR Report Key | 7039634 |
MDR Text Key | 92275558 |
Report Number | 2951238-2017-00728 |
Device Sequence Number | 1 |
Product Code |
FAS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK890328 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other,use |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/16/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | C650-129A |
Device Catalogue Number | C650-129A |
Device Lot Number | 0344AA |
Other Device ID Number | UDI |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/31/2017
|
Initial Date FDA Received | 11/16/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 62 YR |
|
|