Brand Name | RIGID OPTICAL HYSTEROSCOPE |
Type of Device | HOPKINS TELESCOPE 30°, 4 MM, 30 CM |
Manufacturer (Section D) |
KARL STORZ SE & CO. KG |
dr.-karl-storz-strasse 34 |
tuttlingen, 78532 |
GM 78532 |
|
Manufacturer (Section G) |
KARL STORZ SE & CO. KG |
dr.-karl-storz-strasse 34 |
|
tuttlingen, 78532 |
GM
78532
|
|
Manufacturer Contact |
anja
fair
|
2151 e grand ave |
el segundo, CA 90245
|
|
MDR Report Key | 17691479 |
MDR Text Key | 322746995 |
Report Number | 9610617-2023-00231 |
Device Sequence Number | 1 |
Product Code |
FAJ
|
UDI-Device Identifier | 04048551093597 |
UDI-Public | 4048551093597 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K943176 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/16/2023 |
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 | 26105BA |
Device Catalogue Number | 26105BA |
Was Device Available for Evaluation? |
No
|
Date Returned to Manufacturer | 08/21/2023 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/30/2023
|
Initial Date FDA Received | 09/06/2023 |
Supplement Dates Manufacturer Received | 09/07/2023 11/13/2023
|
Supplement Dates FDA Received | 09/07/2023 11/16/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/04/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |