Brand Name | HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS |
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 | 17939063 |
MDR Text Key | 325722604 |
Report Number | 9610773-2023-02939 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 14042761085530 |
UDI-Public | 14042761085530 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K171965 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/26/2024 |
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 | WA47706S |
Device Lot Number | 1000115480 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/20/2023 |
Initial Date FDA Received | 10/16/2023 |
Supplement Dates Manufacturer Received | 03/25/2024
|
Supplement Dates FDA Received | 03/26/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/29/2023 |
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) |
Other;
|
|
|