Brand Name | BIPOLAR HIGH FREQUENCY CORD |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 e grand avenue |
el segundo CA 90245 |
|
MDR Report Key | 15249711 |
MDR Text Key | 298162646 |
Report Number | 15249711 |
Device Sequence Number | 1 |
Product Code |
GEI
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial,Followup |
Report Date |
08/09/2022,08/05/2022 |
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 | UH801 |
Device Catalogue Number | UH801 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/09/2022 |
Device Age | 3 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/17/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/18/2022 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/19/2022
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|