Brand Name | SERFAS ENERGY 90-S CRUISE |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
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 |
lucas
wolski
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 18918168 |
MDR Text Key | 337851809 |
Report Number | 0002936485-2024-00233 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 07613327057034 |
UDI-Public | 07613327057034 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K160050 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/15/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/15/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0279401200 |
Device Lot Number | 23179AE2 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/21/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/28/2023 |
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 |