Brand Name | ICONIX 2 TT WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
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 |
ashley
lower
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 7139523 |
MDR Text Key | 95824515 |
Report Number | 0002936485-2017-01237 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K133671 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nursing Assistant
|
Type of Report
| Initial |
Report Date |
12/21/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/21/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 3910-500-322 |
Device Lot Number | 15309AE2 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/24/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/05/2015 |
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 |