ROSA ONE BRAIN
Report
- Report Number
- 3009185973-2024-00012
- Event Type
- Injury
- Date Received
- September 4, 2024
- Date of Event
- August 5, 2024
- Report Date
- July 23, 2025
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- UDI-DI
- 03760244034793
- PMA / PMN Number
- K214065
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. HOWEVER, THE UNIT IS AVAILABLE FOR A FIELD SERVICE ENGINEER TO LOOK AT ON SITE. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). UPDATED: B4, B5, D2, E, G2, G3, H1, H2, H6, H11. REPORTED EVENT WAS CONFIRMED AS PHYSICAL AND TECHNICAL EVALUATION WERE PERFORMED BY THE FIELD SERVICE ENGINEER (FSE) WHO WAS ON SITE ON TO PERFORM CORRECTIVE MAINTENANCE (CM). DURING THE CM, THE STABILIZATION SYSTEM WAS ADJUSTED SO ALL 4 FEET WERE HITTING THE FLOOR AT THE SAME TIME. AT VARIOUS SPOTS ON THE FLOOR THE ROBOT COULD STILL MOVE SIDE TO SIDE. 3M MICROFOAM TAPE WAS APPLIED TO THE BOTTOM OF THE STABILIZATION FEET TO PROVIDE BETTER FRICTION WITH THE FLOOR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE WEAR ON THE STABILIZATION SYSTEM AND/OR UNEVEN OR FLOORS. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE (UPDATE/CORRECTED) CORRECTED: G4. UPDATED: G3; H2.
IT WAS REPORTED THAT THE ROBOT WAS SLIDING DURING CASE. SUBSEQUENTLY THE CASE HAD TO BE CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA AND INCISION MADE. THE PATIENT HAD TO GO BACK UNDER ANESTHESIA FOUR DAYS LATER, WHEN THE CASE WAS COMPLETED. THE SURGEON DID REPORT BACK TO THE REP THREE DAYS AFTER THE COMPLETED CASE THAT THE PATIENT WAS DOING WELL. NO FURTHER INFORMATION KNOWN.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 883235 | ROSA ONE BRAIN | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTECH SAS | N/A | N/A | 03760244034793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |