ROSA ONE
Report
- Report Number
- 3009185973-2022-00016
- Event Type
- Malfunction
- Date Received
- February 28, 2022
- Date of Event
- January 31, 2022
- Report Date
- August 26, 2022
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- PMA / PMN Number
- K200511
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4).
DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE INACCURACY IS CONFIRMED FOR ALL TWELVE ELECTRODES IMPLANTED AT THE ENTRY POINT. IT WAS FOUND THAT THE DISTANCE SENSOR DID NOT PASS THE ACCURACY TEST IN ONE SHOT AFTER THE CASE. INDEED, A CORRECTIVE ACTION ON STERILE INTERFACE WAS PERFORMED TO GET A CORRECT RESULT. THIS DEVICE INACCURACY COULD HAVE CONTRIBUTED TO THE FINAL INACCURACY OF ELECTRODE POSITIONING THROUGH AUTOMATIC REGISTRATION. MOREOVER, IT WAS ALSO FOUND THAT ALTHOUGH THE LASER REGISTRATION WAS VALIDATED WITH CORRECT RESULTS, IT WAS NOT OPTIMAL REGARDING IFU RECOMMENDATIONS. THE FUSION BETWEEN PRE-OPERATIVE EXAMS ALSO SHOW SHIFTS WHICH COULD ALSO CONTRIBUTE TO THE ACTUAL ELECTRODE PLACEMENT. THE AUTOMATIC MERGE WAS NOT RE-ADJUSTED AS EXPECTED. THE PERFORMANCE ISSUE WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS.
IT WAS REPORTED THAT SURGEON AND CLINICAL REPRESENTATIVE WERE COMPARING THE POST-OPERATIVE AIRO SCAN WITH THE PATIENT PLAN AFTER SURGERY TO SEE ACCURACY WHEN THEY NOTICED EVERY TRAJECTORY WAS 3MM OR MORE OFF, MOSTLY INFERIOR. SURGEON HAD REGISTERED WITH THE LASER, ERROR OF .47MM (FROM THE .ROS). VERIFICATION WAS APPROVED, ONLY ONE POINT WAS OFF THE SKIN (LEFT OUTER CANTHUS). PATIENT WAS PINNED WITH THE CRW FRAME AND CONNECTED TO THE ROSA ROBOT WITH THE CRW FRAME ADAPTOR. NO PATIENT MOVEMENT WAS NOTED. SURGEON AND CLINICAL REPRESENTATIVE CHECK THE POST-OPERATIVE MERGE SEVERAL TIMES. NO NEGATIVE PATIENT IMPACT WAS NOTED. SURGEON SAID DURING PLANNING THEY WERE UNABLE TO MERGE THE T1 WITH GAD IMAGE TO THE CT. THEY ENDED UP MERGING THE T2 IMAGE TO THE CT AND THEN MERGED THE T1 WITH GAD TO THE T2. ALL MERGES LOOKED ACCURATE. SURGEON SAID THIS T1 WITH GAD TO CT MERGE ISSUE HAS HAPPENED A COUPLE TIMES SINCE THE LAST SOFTWARE UPDATE.
IT WAS REPORTED THAT SURGEON AND CLINICAL REPRESENTATIVE WERE COMPARING THE POST-OPERATIVE AIRO SCAN WITH THE PATIENT PLAN AFTER SURGERY TO SEE ACCURACY WHEN THEY NOTICED EVERY TRAJECTORY WAS 3MM OR MORE OFF, MOSTLY INFERIOR. SURGEON HAD REGISTERED WITH THE LASER, ERROR OF .47MM (FROM THE .ROS). VERIFICATION WAS APPROVED, ONLY ONE POINT WAS OFF THE SKIN (LEFT OUTER CANTHUS). PATIENT WAS PINNED WITH THE CRW FRAME AND CONNECTED TO THE ROSA ROBOT WITH THE CRW FRAME ADAPTOR. NO PATIENT MOVEMENT WAS NOTED. SURGEON AND CLINICAL REPRESENTATIVE CHECK THE POST-OPERATIVE MERGE SEVERAL TIMES. NO NEGATIVE PATIENT IMPACT WAS NOTED. SURGEON SAID DURING PLANNING THEY WERE UNABLE TO MERGE THE T1 WITH GAD IMAGE TO THE CT. THEY ENDED UP MERGING THE T2 IMAGE TO THE CT AND THEN MERGED THE T1 WITH GAD TO THE T2. ALL MERGES LOOKED ACCURATE. SURGEON SAID THIS T1 WITH GAD TO CT MERGE ISSUE HAS HAPPENED A COUPLE TIMES SINCE THE LAST SOFTWARE UPDATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 882155 | ROSA ONE | COMPUTER-ASSISTED SURGICAL DEVICE | HAW | MEDTECH SAS | ROSA ONE | 3.1.5.28 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |