Brand Name | HF-RESECTION ELECTRODE, LOOP |
Type of Device | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg, hamburg 22045 |
GM 22045 |
|
Manufacturer (Section G) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
|
hamburg |
|
Manufacturer Contact |
todd
brill
|
800 west park drive |
westborough, MA 01581
|
5082077661
|
|
MDR Report Key | 17914338 |
MDR Text Key | 325413809 |
Report Number | 9610773-2023-02879 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 14042761068205 |
UDI-Public | 14042761068205 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K100275 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/17/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | WA22503D |
Device Lot Number | 1000083333 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/20/2023
|
Initial Date FDA Received | 10/11/2023 |
Supplement Dates Manufacturer Received | 11/10/2023
|
Supplement Dates FDA Received | 11/17/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/06/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 51 YR |
Patient Sex | Female |
|
|