Brand Name | HF-RESECTION ELECTRODE "PLASMALOOP", 24 FR |
Type of Device | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg, hamburg 22045 |
GM 22045 |
|
Manufacturer Contact |
connie
tubera
|
2400 ringwood avenue |
san jose, CA 95131
|
4089355124
|
|
MDR Report Key | 8201480 |
MDR Text Key | 131916705 |
Report Number | 2951238-2018-00817 |
Device Sequence Number | 1 |
Product Code |
FAS
|
UDI-Device Identifier | 14042761085332 |
UDI-Public | 14042761085332 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K171965 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other,use |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/27/2018 |
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 | WA22703S |
Device Lot Number | 1000022942 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/06/2018 |
Initial Date FDA Received | 12/27/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 Age | 68 YR |
Patient Weight | 98 |
|
|