Brand Name | STORZ 11278AU1 (FLEX-X) SCOPE URETEROSCOPE |
Type of Device | URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
Manufacturer (Section D) |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CA |
|
MDR Report Key | 13333991 |
MDR Text Key | 284378920 |
Report Number | MW5106891 |
Device Sequence Number | 1 |
Product Code |
FGB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
01/19/2022 |
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 Model Number | STORZ 11278AU1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 01/21/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 62 YR |
Patient Sex | Male |
|
|