Brand Name | CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR. |
Type of Device | BIPOLAR ELECTRODE |
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 |
susie
chen
|
2151 e. grand avenue |
el segundo, CA 90245-5017
|
4242188201
|
|
MDR Report Key | 10909737 |
MDR Text Key | 219137842 |
Report Number | 9610617-2020-00134 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 04048551393864 |
UDI-Public | 4048551393864 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061541 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/29/2020 |
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 | 27040GP130-S |
Device Catalogue Number | 27040GP130-S |
Device Lot Number | 37CJ2529 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
10/29/2020
|
Initial Date FDA Received | 11/26/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|