ROSA ONE (JP)
Report
- Report Number
- 3009185973-2024-00007
- Event Type
- Injury
- Date Received
- July 11, 2024
- Date of Event
- June 13, 2024
- Report Date
- February 7, 2025
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- PMA / PMN Number
- K200511
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO POST-OPERATIVE SCAN WAS AVAILABLE FOR THE INVESTIGATION. AS A RESULT, THE PRESENCE OF THE INTRACRANIAL HEMORRHAGE AND POTENTIAL INACCURACY OF THE ELECTRODE PLACEMENT CANNOT BE CONFIRMED. THE ROSA LOGS WERE REVIEWED, AND THE FOLLOWING FACTS WERE IDENTIFIED: FUSION: BASED ON THE LOGS, THE FUSION BETWEEN THE PLANNING EXAM (¿EXAM 1¿) AND THE EXAM USED DURING REGISTRATION (¿FIDUCIALS¿) WAS SATISFACTORY TO THE SURGEON AND DID NOT REQUIRE ANY MANUAL OR MICRO ADJUSTMENTS. HOWEVER, RECREATION OF THIS FUSION IN SIMULATOR FOUND THAT THE TWO EXAMS WERE NOT COMPLETELY ALIGNED. IT IS UNKNOWN IF THIS SMALL MISALIGNMENT HAD ANY EFFECT ON THE FINAL ELECTRODE PLACEMENT. SECTION 4.3.3.5 FUSION VALIDATION OF THE BRAIN APPLICATION USER MANUAL WARNS THE USER TO NOT ACCEPT POOR FUSION QUALITY. IF ANY DOUBT IN THE IMAGE QUALITY OF THE MERGED EXAM (E.G. ARTIFACT, BLURRED AREAS, SHIFT OR OTHER SUSPICIOUS DISPLAY IN THE ROI), REVIEW THE FUSION AND / OR SELECT ANOTHER 3D EXAM. REGISTRATION AND VERIFICATION: MARKER REGISTRATION WAS PERFORMED AND RESULTED IN A RMS VALUE WITHIN THE THRESHOLD. REVIEW OF VERIFICATION SCREENSHOTS CONFIRMED THAT VERIFICATION WAS PERFORMED ON THE CORRECT ANATOMICAL POINTS. ALL POINTS WERE WITHIN THE SYSTEM¿S THRESHOLD. REVIEW OF MAINTENANCE RECORDS: A FULL PREVENTIVE MAINTENANCE WAS PERFORMED APPROXIMATELY 2 MONTHS PRIOR TO THE REPORTED SURGERY. ALL ACCURACY AND APPLICATIVE TESTS PASSED, AND THE FIELD SERVICE ENGINEER CONFIRMED THAT THE ROSA UNIT WAS FULLY FUNCTIONAL. THE NEXT PREVENTIVE MAINTENANCE WAS PERFORMED APPROXIMATELY 1 WEEK AFTER. AGAIN, THE SYSTEM PASSED ALL ACCURACY AND APPLICATIVE TESTS. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE AT THIS TIME. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT UNDERWENT ROSA ONE-ASSISTED IMPLANTATION OF 7 DEEP ELECTRODES. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT'S CT SCAN SHOWED NO BLEEDING. HOWEVER, THE PATIENT'S PHYSICIAN LATER REPORTED THAT THERE WAS AN INTRACRANIAL HEMORRHAGE THAT DID NOT REQUIRE THERAPEUTIC INTERVENTION. THE PATIENT HAS NO SYMPTOMS AND IS PLACED IN THE INTENSIVE CARE UNIT FOR OBSERVATION. APPROXIMATELY 12 DAYS POST OPERATION, NO MEDICAL INTERVENTION, AND THE PATIENT DIDN¿T FEEL THE SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2380669 | ROSA ONE (JP) | MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM | HAW | MEDTECH SAS | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Male | Other| H |