ROSA ONE BRAIN
Report
- Report Number
- 3009185973-2024-00004
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- April 26, 2024
- Report Date
- July 22, 2025
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- UDI-DI
- 03760244032492
- PMA / PMN Number
- K214065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A FULL ANALYSIS OF THE DATA LOGS WAS PERFORMED. REVIEW OF THE MR POST ¿ MR SCAN CONFIRMED THE REPORTED INACCURACY. WHILE NO ELECTRODE IS VISIBLE IN THE SCAN, THE DISTANCE BETWEEN THE NEGATIVE SPACE AND THE PLANNED TRAJECTORY COULD STILL BE MEASURED, AND WAS FOUND TO BE OVER 3 MM. HOWEVER, PER THE COMPLAINT DESCRIPTION, THE SURGEON WAS STILL ABLE TO USE THE TRAJECTORY TO COMPLETE THE ABLATION SUCCESSFULLY. REVIEW OF THE LOG FILES AND SCREENSHOTS FOUND THAT THE REGISTRATION VERIFICATION PROCESS WAS NOT OPTIMAL, WHICH CAN IMPACT SYSTEM PERFORMANCE AND ACCURACY. EVALUATION OF THE SCREENSHOTS FOR REGISTRATION VERIFICATION STEPS 6 AND 7 INDICATES THAT THE LASER REMAINED ON THE PATIENT¿S RIGHT SIDE WHILE MEASURING THE FEATURES ON THE LEFT SIDE OF THE PATIENT¿S FACE. THIS GOES AGAINST SECTION 2.4.1.3 SURFACE MATCHING REGISTRATION OF THE ACDC-041B-US ROSA ONE BRAIN APPLICATION USER MANUAL: 'WHENEVER POSSIBLE, THE ORIENTATION OF THE DISTANCE SENSOR MUST BE PERPENDICULAR TO THE REGISTRATION ZONE.' ADDITIONALLY, FOR STEP 7 THE LASER WAS POINTED ABOVE THE PATIENT'S LEFT EYE INSTEAD OF AT THE PATIENT¿S LEFT OUTER CANTHUS. SECTION 2.4.2 ACCURACY VERIFICATION PROCEDURE SPECIFIES WHICH ANATOMICAL POINTS ARE REQUIRED. PER THIS SAME SECTION 'IT IS HIGHLY RECOMMENDED TO CARRY OUT THE VERIFICATION IN ORDER TO OBTAIN OPTIMAL PERFORMANCE.' THERE WAS NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DURING THE PROCEDURE, A PROGRAM DEVELOPMENT ASSOCIATE (PDA) NOTED THAT THE VALUES ON THE SICK BOX WERE NOT CORRECT. PER THE COMPLAINT DESCRIPTION, THE PDA WAS ABLE TO CORRECT THIS BY POWERING THE SICK BOX OFF AND BACK ON. AS PER THE DESIGN DEFECT, AR-2251, THIS ANOMALY WOULD NOT SIGNIFICANTLY IMPACT ODS ACCURACY. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND FOR THE REPORTED PART AND SERIAL COMBINATION. THE OVERALL CALCULATED OCCURRENCE COMPLETED IN SECTION 4.3.3 C WAS COMPARED TO THE APPLICABLE RISK DOCUMENTATION. THE CALCULATED OCCURRENCE IS WITHIN THE ACCEPTABLE LIMITS DICTATED BY THE RISK MANAGEMENT FILE. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE ODS SICK BOX PARAMETERS REVERTING TO THE FACTORY DEFAULT SETTINGS IS A DESIGN DEFECT DOCUMENTED UNDER (B)(4). THE ISSUE HAS BEEN ESCALATED FOR FURTHER EVALUATION UNDER (B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT FOR A LASER ABLATION SURGERY, THE PATIENT HAD AN MRI BEFORE LASER ABLATION TO CONFIRM PLACEMENT AND THE TRAJECTORY WAS ROUGHLY 2MM OFF FROM BOTH ENTRY & TARGET. FEILD SERVICE ENGINEER REPORTED TO HAVE MERGED THE POST OP MRI TO ROSA TO CONFIRM THAT THE TRAJECTORY WAS IN FACT OFF. FEILD SERVICE ENGINEER REPORTED NOTICING CHANGES IN THE VALUES ON THE SICK BOX, AND IT WAS OBSERVED THAT THE VALUES WERE IN FACT NOT CORRECT. FEILD SERVICE ENGINEER REPORTED TO HAVE TURNED THE SICK BOX OFF AND ON, TO CHANGE THE VALUES TO THE CORRECT NUMBER. THE SURGEON WAS STILL ABLE TO USE THE TRAJECTORY TO COMPLETE THE ABLATION SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1426416 | ROSA ONE BRAIN | MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM | HAW | MEDTECH SAS | N/A | 3.1.6.432 | 03760244032492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |