ROSA ONE
Report
- Report Number
- 3009185973-2019-00119
- Event Type
- Malfunction
- Date Received
- April 5, 2019
- Report Date
- January 18, 2022
- Manufacturer
- MEDTECH SAS
- Product Code
- OLO
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THE CANNULA STAYS BLOCKED IN THE SHORT CANNULA ADAPTOR SOMETIMES. PRODUCT RETURN WAS REQUESTED FOR INVESTIGATION. MULTIPLE ATTEMPTS WERE PERFORMED TO REQUEST THE PRODUCT HOWEVER THE FIELD SERVICE ENGINEER CONFIRMED ON 19 SEP 2019 THAT THE ADAPTOR IS UNTRACEABLE. AS THE PRODUCT LOCATION IS UNKNOWN, NO ANALYSIS CAN BE PERFORMED AND THE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CLOSED AS IS AND WILL BE RE-OPENED SHOULD THE PART BE RECEIVED IN THE FUTURE.
IT WAS REPORTED THAT THE 5.95 SHORT SPINE ADAPTOR DOES NOT LET THE CANULA SLIDE IN. THE SHORT SPINE ADAPTOR S/N (B)(6) AND THE CANULA (B)(6) WERE RETURNED AT MANUFACTURING SITE FOR INVESTIGATION. VISUAL INSPECTION DID NOT SHOW ANY PHYSICAL DAMAGE. MECHANICAL TESTING CONFIRMED THAT THE CANULA CANNOT BE INSERTED IN THE SHORT SPINE ADAPTOR. THIS IS A KNOWN DESIGN ISSUE, THAT LEAD TO A DESIGN CHANGE OF THE SHORT SPINE ADAPTOR. THE EVENT DESCRIBED IN THE COMPLAINT IS CONFIRMED.
DURING REVIEW OF THE COMPLAINT FOR CLOSURE, IT WAS NOTICED THAT AN INCORRECT PRODUCT CODE WAS SENT IN THE INITIAL REPORT 3009185973-2019-00119.
THE FIELD SERVICE ENGINEER (FSE) RECEIVED AN EMAIL ON MARCH THU. 7TH FROM NURSE TO INFORM HIM THE 5.95MM SHORT ADAPTERS USED FOR SPINE SURGERIES WERE NOT LETTING THE CANULAS SLIDE IN SOMETIMES. THE FSE WAS ON SITE, AND CONFIRMED THE ISSUE WITH ONLY ONE ADAPTER OUT OF THE THREE ON SITE.
THE FIELD SERVICE ENGINEER (FSE) RECEIVED AN EMAIL ON MARCH THU. 7TH FROM NURSE TO INFORM HIM THE 5.95MM SHORT ADAPTERS USED FOR SPINE SURGERIES WERE NOT LETTING THE CANULAS SLIDE IN SOMETIMES. THE FSE WAS ON SITE, AND CONFIRMED THE ISSUE WITH ONLY ONE ADAPTER OUT OF THE THREE ON SITE.
THE FIELD SERVICE ENGINEER (FSE) RECEIVED AN EMAIL ON MARCH THU. 7TH FROM NURSE TO INFORM HIM THE 5.95MM SHORT ADAPTERS USED FOR SPINE SURGERIES WERE NOT LETTING THE CANULAS SLIDE IN SOMETIMES. THE FSE WAS ON SITE, AND CONFIRMED THE ISSUE WITH ONLY ONE ADAPTER OUT OF THE THREE ON SITE.
THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THE DEVICE MODEL ROSA ONE SPINE APPLICATION IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA SPINE 1.0.2, CLASSIFIED OLO AND CLEARED UNDER (B)(4).
THE FIELD SERVICE ENGINEER (FSE) RECEIVED AN EMAIL ON MARCH THU. 7TH FROM NURSE TO INFORM HIM THE 5.95MM SHORT ADAPTERS USED FOR SPINE SURGERIES WERE NOT LETTING THE CANULAS SLIDE IN SOMETIMES. THE FSE WAS ON SITE, AND CONFIRMED THE ISSUE WITH ONLY ONE ADAPTER OUT OF THE THREE ON SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282840 | ROSA ONE | COMPUTER-ASSISTED SURGICAL DEVICE | OLO | MEDTECH SAS | SHORT SPINE ADP - SST | ROSA3-117B | |
| 282841 | ROSA ONE | COMPUTER-ASSISTED SURGICAL DEVICE | OLO | MEDTECH SAS | SHORT SPINE ADP - SST | ROSA3-117B | |
| 282842 | ROSA ONE | COMPUTER-ASSISTED SURGICAL DEVICE | OLO | MEDTECH SAS | SHORT SPINE ADP - SST | ROSA3-117B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |