Brand Name | 22 FR, 0 DEGREE (STRAIGHT) CUTTING LOOP ELECTRODE, .014 |
Type of Device | ELECTRODE, ELECTRO SURGICAL, ACTIVE, UROLOGICAL |
Manufacturer (Section D) |
STRYKER ENDOSCOPY-SAN JOSE |
5900 optical court |
san jose CA 95138 |
|
Manufacturer (Section G) |
STRYKER ENDOSCOPY-SAN JOSE |
5900 optical court |
|
san jose CA 95138 |
|
Manufacturer Contact |
kimberly
lynch
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 4877024 |
MDR Text Key | 6045648 |
Report Number | 0002936485-2015-00551 |
Device Sequence Number | 1 |
Product Code |
FAS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K040390 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative,company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/03/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/29/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0504990500 |
Device Lot Number | 37576 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/05/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/03/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|