Brand Name | LIGHT SOURCE, 500XL, XENON |
Type of Device | ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
oklahoma city OK 73107 6512 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
|
oklahoma city OK 73107 6512 |
|
Manufacturer Contact |
jim
gonzales
|
7000 w william cannon dr. |
austin, TX 78735
|
5123585706
|
|
MDR Report Key | 6147645 |
MDR Text Key | 61867219 |
Report Number | 1643264-2016-00267 |
Device Sequence Number | 1 |
Product Code |
FFS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K994084 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/24/2017 |
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 |
Health Professional
|
Device Catalogue Number | 72200568 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/25/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/05/2016 |
Initial Date FDA Received | 12/06/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/24/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/18/2015 |
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 |
|
|