Brand Name | PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE |
Type of Device | CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
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 |
andrea
zenere
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 7997091 |
MDR Text Key | 124810895 |
Report Number | 0002936485-2018-00664 |
Device Sequence Number | 1 |
Product Code |
FAJ
|
Combination Product (Y/N) | N |
Reporter Country Code | CA |
PMA/PMN Number | K040390 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
USER FACILITY |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
07/14/2019 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 10/23/2018 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | 0504880314 |
Device LOT Number | STENCC01 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 10/15/2018 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 10/03/2018 |
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
|
|
|