Brand Name | PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30°, 140MM, SPEED-LOCK |
Type of Device | ARTHROSCOPE |
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 | 12733735 |
MDR Text Key | 279526267 |
Report Number | 0002936485-2021-00590 |
Device Sequence Number | 1 |
Product Code |
HRX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K183470 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
01/12/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/01/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 0502-404-030 |
Device Catalogue Number | 0502404030 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/15/2021 |
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 |
Reuse
|
Patient Treatment Data |
Date Received: 11/01/2021 Patient Sequence Number: 1 |
|
|