Brand Name | VIDEO URETEROSCOPE 8.5 FR |
Type of Device | FLEXIBLE VIDEO URETEROSCOPE |
Manufacturer (Section D) |
KARL STORZ SE & CO. KG |
dr.-karl-storz-strasse 34 |
78532 |
tuttlingen, gm |
|
Manufacturer (Section G) |
KARL STORZ SE & CO.KG |
dr.-karl-storz -strasse 34 |
78532 |
tuttlingen, gm |
|
Manufacturer Contact |
anja
fair
|
2151 e. grand avenue |
el segundo, CA 90245
|
4242188100
|
|
MDR Report Key | 14336446 |
MDR Text Key | 292595423 |
Report Number | 9610617-2022-00069 |
Device Sequence Number | 1 |
Product Code |
FGB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141250 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
05/09/2022 |
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 | R11278VSUEK |
Device Catalogue Number | R11278VSUEK |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/08/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/02/2020 |
Initial Date FDA Received | 05/09/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/24/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|