Brand Name | CAMERA CONTROL UNIT, HIGH DEF, 560P |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
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 west william cannon drive |
austin, TX 78735
|
5123585706
|
|
MDR Report Key | 8364695 |
MDR Text Key | 137376909 |
Report Number | 1643264-2019-00139 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 03596010643094 |
UDI-Public | 03596010643094 |
Combination Product (y/n) | N |
Reporter Country Code | EG |
PMA/PMN Number | K070266 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/22/2019 |
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 | 72201919 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/09/2019 |
Initial Date FDA Received | 02/24/2019 |
Supplement Dates Manufacturer Received | 02/25/2019 04/18/2019
|
Supplement Dates FDA Received | 02/28/2019 04/22/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|