Brand Name | HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12° |
Type of Device | HF-RESECTION ELECTRODE |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg, hamburg/de/germany 22045 |
GM 22045 |
|
Manufacturer (Section G) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
|
hamburg, hamburg/de/germany 22045 |
GM
22045
|
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 18941933 |
MDR Text Key | 339100218 |
Report Number | 9610773-2024-00795 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 14042761051665 |
UDI-Public | 14042761051665 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K120418 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Remedial Action |
Relabeling |
Type of Report
| Initial |
Report Date |
03/20/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/20/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | WA22302D |
Device Lot Number | 1000120099 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/14/2024 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/10/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/05/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-2413-2023 |
Patient Sequence Number | 1 |
|
|