MAUDE Adverse Event Report: MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA ONE

Device Problems Computer Software Problem (1112); Unintended Collision (1429)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Udi#: (b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.

Event Description

Reportedly, the iso centric point calibration method for the endoscopic mode has changed with the recent software update.Therefore the surgeon did not set up the isocentric point on the endoscope before sending the robot arm to trajectory and did not anticipate the robot arm trajectory.The endoscopic sheath was bend by the rosa one device.The surgery was reverted to traditional surgery following this event.

Event Description

Reportedly, the iso centric point calibration method for the endoscopic mode has changed with the recent software update.Therefore the surgeon did not set up the isocentric point on the endoscope before sending the robot arm to trajectory and did not anticipate the robot arm trajectory.The endoscopic sheath was bend by the rosa one device.The surgery was reverted to traditional surgery following this event.

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.A detailed analysis of the data logs has been performed and concluded that the iso center was not defined by default at the entry point of the planned trajectory, as in the previous version of the product and as indicated in the user manual.As the user was not informed of that change, an unexpected arm movement was experienced in cooperative mode during the ventricular endoscopy procedure.Note: the iso center could still be adjusted by the user, so the above-mentioned change is not the direct cause for the issue.The thorough analysis and tests performed at the manufacturer¿s site permitted to determine that a software anomaly affecting the endoscopy module of rosa one 3.1 brain application led to a transient deactivation of the security zone followed by an unexpected blockage of the robot arm.While the deactivation of the security zone was not detected in the sole complaint report received to date, the subsequent blockage of the robot arm followed by an impact of the endoscope sheath with the skull bone, led the user to switch to traditional surgery.The two issues described above were addressed through the field safety corrective action referred to as zfa-2021-00063 (ansm reference (b)(4)).

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 11587368
• MDR Text Key: 247276965
• Report Number: 3009185973-2021-00089
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00209
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other