Brand Name | ROSA SURGICAL DEVICE |
Type of Device | COMPUTER-ASSISTED SURGICAL DEVICE |
Manufacturer (Section D) |
MEDTECH SA |
zac eureka |
900 rue du mas de verchant |
montpellier, languedoc-roussillon 34000 |
FR 34000 |
|
Manufacturer (Section G) |
MEDTECH SA |
zac eureka |
900 rue du mas de verchant |
montpellier, languedoc-roussillon 34000 |
FR
34000
|
|
Manufacturer Contact |
jay
sharma
|
zac eureka |
900 rue du mas de verchant |
montpellier, languedoc-roussillon 34000
|
FR
34000
|
7414400
|
|
MDR Report Key | 6463874 |
MDR Text Key | 71895477 |
Report Number | 3009185973-2017-00362 |
Device Sequence Number | 1 |
Product Code |
HAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101791 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
03/30/2017 |
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 |
No Information
|
Device Model Number | ROSA 2.5.8 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/21/2015 |
Initial Date FDA Received | 04/06/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/18/2014 |
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 |