Brand Name | CUTTING LOOP, BIPOLAR, 24/26 FR. |
Type of Device | CUTTING LOOP, BIPOLAR, 24/26 FR. |
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 |
christiane
klaiber
|
dr.-karl-storz-strasse 34 |
tuttlingen, 78532
|
GM
78532
|
|
MDR Report Key | 17992722 |
MDR Text Key | 326362251 |
Report Number | 9610617-2023-00312 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 04048551393482 |
UDI-Public | 4048551393482 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K221893 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
10/23/2023 |
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 | 27040GP1-S |
Device Catalogue Number | 27040GP1-S |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 10/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |