Brand Name | CYSTOSCOPE SHEATH, 22 FR. |
Type of Device | CYSTO SHEATH |
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 ave |
el segundo, CA 90245-5017
|
4242188738
|
|
MDR Report Key | 15075059 |
MDR Text Key | 296307935 |
Report Number | 9610617-2022-00121 |
Device Sequence Number | 1 |
Product Code |
ODB
|
UDI-Device Identifier | 04048551098127 |
UDI-Public | 4048551098127 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/11/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 27026B |
Device Catalogue Number | 27026B |
Device Lot Number | PS10 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/05/2022
|
Initial Date FDA Received | 07/21/2022 |
Supplement Dates Manufacturer Received | 08/11/2022
|
Supplement Dates FDA Received | 08/11/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2017 |
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) |
Required Intervention;
|
|
|