Brand Name | STRYKER AHTO TUBE SET WITH TIP PACKAGING |
Type of Device | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
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 |
chester
rebugio
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 18899178 |
MDR Text Key | 337635369 |
Report Number | 0002936485-2024-00223 |
Device Sequence Number | 1 |
Product Code |
GCX
|
UDI-Device Identifier | 37613327061650 |
UDI-Public | 37613327061650 |
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K042454 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
03/13/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/13/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0250070620 |
Device Lot Number | 23256FG2 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/19/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/13/2023 |
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 |
|
|