Brand Name | UNIDRIVE GYN MOTOR SYSTEM |
Type of Device | GYN MORCELLATOR |
Manufacturer (Section D) |
KARL STORZ SE & CO. KG |
dr.-karl-storz-strasse 34 |
78532 |
tuttlingen, gm, |
GM |
|
Manufacturer (Section G) |
KARL STORZ SE & CO.KG |
dr.-karl-storz -strasse 34 |
78532 |
tuttlingen, gm, |
GM
|
|
Manufacturer Contact |
anja
fair
|
2151 e. grand avenue |
el segundo
|
|
MDR Report Key | 14525366 |
MDR Text Key | 293258897 |
Report Number | 9610617-2022-00079 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K010346 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign |
Reporter Occupation |
505
|
Type of Report
| Initial |
Report Date |
05/31/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 26711101-1 |
Device Catalogue Number | 26711101-1 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/16/2022 |
Initial Date FDA Received | 05/27/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
Disability;
|
Patient Sex | Female |
|
|