Brand Name | BIPOLAR CUTTING LOOP, DIAMETER 0.30MM |
Type of Device | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
Manufacturer (Section D) |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
el segundo CA 90245 |
|
MDR Report Key | 12961206 |
MDR Text Key | 282036019 |
Report Number | MW5105922 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 00404855139387 |
UDI-Public | 01004048551393871 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/06/2021 |
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 Lot Number | 37BA2547 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/07/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 22 YR |
Patient Sex | Female |
Patient Weight | 67 KG |
Patient Ethnicity | Hispanic |
|
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