Brand Name | LEKSELL STEREOTACTIC SYSTEM |
Type of Device | NEUROLOGICAL STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
ELEKTA INSTRUMENT AB |
kungstensgatan 18 |
po box 7593 |
stockholm, SE103 93 |
SW SE103 93 |
|
Manufacturer (Section G) |
ELEKTA INSTRUMENT AB |
kungstensgatan 18 |
po box 7593 |
stockholm, SE103 93 |
SW
SE103 93
|
|
Manufacturer Contact |
pms
|
linac house |
fleming way |
crawley, west sussex RH10 -9RR
|
UK
RH10 9RR
|
|
MDR Report Key | 9346303 |
MDR Text Key | 203339247 |
Report Number | 9612186-2019-00010 |
Device Sequence Number | 1 |
Product Code |
HAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K152558 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other,use |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/20/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/21/2019 |
Initial Date FDA Received | 11/20/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|