Brand Name | PKG, 5MM PEEK MONOPOLAR HANDLE |
Type of Device | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED |
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 |
roomi banerjee
dua
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 7456997 |
MDR Text Key | 106876594 |
Report Number | 0002936485-2018-00370 |
Device Sequence Number | 1 |
Product Code |
OCZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K973259 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/24/2018 |
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 |
Other
|
Device Catalogue Number | 0250080617 |
Device Lot Number | 1342852H |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2018 |
Initial Date Manufacturer Received |
03/28/2018
|
Initial Date FDA Received | 04/24/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |