ROSA ONE
Report
- Report Number
- 3009185973-2021-00181
- Event Type
- Malfunction
- Date Received
- November 8, 2021
- Date of Event
- October 7, 2021
- Report Date
- January 27, 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
- FL, US
- Reporter Occupation
- 003
Narratives
A DETAILED HARDWARE INVESTIGATION WAS PERFORMED ON THE RETURNED PART AND NO SPECIFIC ANOMALY WAS FOUND ON THE VIGILANCE DEVICE (FOOT PEDAL), ITS CABLE OR ITS CONNECTOR. THE INFORMATION PROVIDED ABOUT THE ENVIRONMENT OF THE ROBOT WHEN THE ISSUE OCCURRED REVEALED THAT THE REPORTED INAPPROPRIATE ACTIVATION OF THE VIGILANCE DEVICE WAS MOST LIKELY PROVOKED BY THE UNEXPECTED PROXIMITY OF AN MRI DEVICE. INDEED, THE VIGILANCE DEVICE CONTAINS REED SWITCHES / HALL EFFECT SENSORS WHICH CAN BE ACTIVATED BY STRONG MAGNETIC FIELDS. TROUBLESHOOTING TESTS CONFIRMED THAT THE ELECTROMAGNETIC LEAKS COMING FROM THE MRI DEVICE ¿ WITH A SUFFICIENT PROXIMITY - COULD EXPOSE THE VIGILANCE DEVICE TO MAGNETIC FIELDS THAT ARE STRONG ENOUGH TO ACTIVATE THE SWITCHES/SENSORS WITHOUT APPLYING ANY MECHANICAL PRESSURE ON THE PEDAL. THE DEVICE IS LABELED "MR UNSAFE" AND THE USER MANUAL ADEQUATELY INDICATES THAT THE DEVICE SHOULD NOT BE USED CLOSE TO AN MRI DEVICE. THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS REGARDING THE MRI DEVICES SAFETY WARNINGS AND RESTRICTIONS FOR USE.
THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4).
AFTER SURGERY WHILE SHUTTING DOWN THE SOFTWARE, ROBOT PROMPTED TO PRESS VIGILANCE DEVICE TO MOVE TO THE PARKING POSITION. WITHOUT ANY EXTERNAL PRESSURE ON THE VIGILANCE DEVICE, THE ROBOT BEGAN TO MOVE INDEPENDENTLY TO THE PARKING POSITION. NO WIRES WERE PINCHED AND THE VIGILANCE DEVICE WAS NOT UPSIDE DOWN. THE CLINICAL REPRESENTATIVE (CR) IMMEDIATELY NOTICED THIS WAS UNUSUAL AND PICKED UP THE VIGILANCE DEVICE OFF THE GROUND. UPON PICKING IT UP, MOVEMENT STOPPED AND ROBOT PROMPTED THE MESSAGE TO PRESS THE VIGILANCE DEVICE TO CONTINUE MOVEMENT. CR CHOSE TO CONTINUE, AND AGAIN WITHOUT ANY EXTERNAL PRESSURE ON THE PEDAL, THE ROBOT COMPLETED ITS MOVEMENT TO THE PARKING POSITION. CR RESTARTED THE ROBOT AND OPENED KINEVERIF TO TEST CONNECTION, MOVEMENT TO HOME, AND BACK TO PARK. CR ALSO TESTED PARKING IN ROSA BRAIN AFTER EXITING THE SOFTWARE. THE UNUSUAL INDEPENDENT ROBOT PARKING DID NOT OCCUR AGAIN.
AFTER SURGERY WHILE SHUTTING DOWN THE SOFTWARE, ROBOT PROMPTED TO PRESS VIGILANCE DEVICE TO MOVE TO THE PARKING POSITION. WITHOUT ANY EXTERNAL PRESSURE ON THE VIGILANCE DEVICE, THE ROBOT BEGAN TO MOVE INDEPENDENTLY TO THE PARKING POSITION. NO WIRES WERE PINCHED AND THE VIGILANCE DEVICE WAS NOT UPSIDE DOWN. THE CLINICAL REPRESENTATIVE (CR) IMMEDIATELY NOTICED THIS WAS UNUSUAL AND PICKED UP THE VIGILANCE DEVICE OFF THE GROUND. UPON PICKING IT UP, MOVEMENT STOPPED AND ROBOT PROMPTED THE MESSAGE TO PRESS THE VIGILANCE DEVICE TO CONTINUE MOVEMENT. CR CHOSE TO CONTINUE, AND AGAIN WITHOUT ANY EXTERNAL PRESSURE ON THE PEDAL, THE ROBOT COMPLETED ITS MOVEMENT TO THE PARKING POSITION. CR RESTARTED THE ROBOT AND OPENED KINEVERIF TO TEST CONNECTION, MOVEMENT TO HOME, AND BACK TO PARK. CR ALSO TESTED PARKING IN ROSA BRAIN AFTER EXITING THE SOFTWARE. THE UNUSUAL INDEPENDENT ROBOT PARKING DID NOT OCCUR AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1670891 | ROSA ONE | COMPUTER-ASSISTED SURGICAL DEVICE | HAW | MEDTECH SAS | ROSA ONE 3.1 | 3.1.5.28 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |