Brand Name | JAWS INSERT "HICURA", 5 X 330, PRECISION SCISSORS, MONOPOLAR |
Type of Device | HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR |
Manufacturer (Section D) |
OLYMPUS WINTER & IBE GMBH |
kuehnstrasse 61 |
hamburg 22045 |
GM 22045 |
|
MDR Report Key | 10913198 |
MDR Text Key | 219375524 |
Report Number | 9610773-2020-00280 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 04042761083652 |
UDI-Public | 04042761083652 |
Combination Product (y/n) | N |
PMA/PMN Number | K140624 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Type of Report
| Initial,Followup |
Report Date |
12/16/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/27/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | WA69378M |
Device Catalogue Number | WA69378M |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/16/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | OLYMPUS HANDLE "HICURA", SIZE M, MONOPOLAR; OLYMPUS SHAFT "HICURA", 5 X 330, MONOPOLAR |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|