Brand Name | LOOP T-BAR ELECTRODE W20 D15 |
Type of Device | ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
kalamazoo MI 49001 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-IRELAND |
instruments division |
carrigtwohill bus. & tech park |
carrigtwohill NA |
EI
NA
|
|
Manufacturer Contact |
colette
chung
|
instruments division |
carrigtwohill bus. & tech park |
carrigtwohill NA
|
EI
NA
|
214532900
|
|
MDR Report Key | 18152862 |
MDR Text Key | 328319365 |
Report Number | 0001811755-2023-00233 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 37613327297899 |
UDI-Public | 37613327297899 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K153679 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional |
Reporter Occupation |
Nurse Practitioner
|
Type of Report
| Initial,Followup |
Report Date |
02/07/2024 |
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 Catalogue Number | 0703320015 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/18/2023
|
Initial Date FDA Received | 11/16/2023 |
Supplement Dates Manufacturer Received | 01/24/2024
|
Supplement Dates FDA Received | 02/07/2024
|
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 |