Brand Name | ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR |
Type of Device | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - MARLBOROUGH |
100 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
MEDICAL SCIENTIFIC |
125 john hancock road |
|
taunton MA 02780 |
|
Manufacturer Contact |
nancy
cutino
|
100 boston scientific way |
marlborough, MA 01752
|
5086834000
|
|
MDR Report Key | 5682464 |
MDR Text Key | 46019286 |
Report Number | 3005099803-2016-01497 |
Device Sequence Number | 1 |
Product Code |
KNS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K913881 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
05/13/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/26/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | M00540200 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/13/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/16/2005 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |