Brand Name | PROBE SAPHYRE 90DEG |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
150 minuteman road |
andover MA 01810 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
150 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 15491797 |
MDR Text Key | 300634658 |
Report Number | 3003604053-2022-00051 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 03596010470560 |
UDI-Public | 03596010470560 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K991218 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
08/16/2023 |
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 Expiration Date | 03/19/2024 |
Device Model Number | 7209686 |
Device Catalogue Number | 7209686 |
Device Lot Number | 2070671 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/07/2022 |
Initial Date FDA Received | 09/27/2022 |
Supplement Dates Manufacturer Received | 09/07/2022 08/11/2023
|
Supplement Dates FDA Received | 09/28/2022 08/16/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/19/2021 |
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 |
Patient Age | 65 YR |
Patient Sex | Male |