Brand Name | ROSA ONE |
Type of Device | COMPUTER-ASSISTED SURGICAL DEVICE |
Manufacturer (Section D) |
MEDTECH SAS |
432 rue du rajol |
mauguio, languedoc-roussillon 34130 |
FR 34130 |
|
Manufacturer (Section G) |
MEDTECH SAS |
432 rue du rajol |
|
mauguio, languedoc-roussillon 34130 |
FR
34130
|
|
Manufacturer Contact |
jay
sharma
|
1520 tradeport drive |
jacksonville, FL 32218
|
9047414400
|
|
MDR Report Key | 13585682 |
MDR Text Key | 286009504 |
Report Number | 3009185973-2022-00007 |
Device Sequence Number | 1 |
Product Code |
HAW
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K200511 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/23/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | ROSA ONE |
Device Catalogue Number | ROSAS00201 |
Device Lot Number | 3.1.5.28 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/24/2022 |
Initial Date FDA Received | 02/23/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/16/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|