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

Model Number ROSA ONE 3.1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

Surgeon at (b)(6) was getting ready to drill the third trajectory of a seeg.Two depth electrodes had been placed on the right side of the head previously.The third trajectory was the first one on the left side.Surgeon said there was movement of the leksell frame when they pushed the drill against the head.Field service engineer (fse) and hospital employee looked under the sterile drapes to check the adaptor connections.When surgeon reenacted the movement, fse noticed leskell moving slightly against the leksell stereotactic system clamp.Fse tightened clamp slightly and movement was reduced.Surgeon drove back to the first two trajectories to see if there had been shift.The trajectories lined up.Fse then created a trajectory to the front left leksell frame pin to check for shift on the left side.On this trajectory the target was noticeably off laterally.Surgeon disconnected patient and got an airo ct scan to check placement.Both leads placed on the right were deep by 8mm and 9mm respectively.Surgeon decided to pull those leads back to the correct depth, wake the patient up and get a real ct.Remaining depths of the surgery were postponed.

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of data logs and patient files was performed and concluded that although the registration verification was not performed according to recommendation, the two first electrodes were correctly implanted at the entry point and the device operated as expected.The error in depth was also confirmed per analysis.Yet, as the error at the entry point is correct and that the electrode was implanted straight, the issue cannot be related to a device non conformity.The depth of the electrode inside the brain depends on various factors, including - but not limited to the curvature of the electrode inside the brain and/or the method of implantation.Due to the drilling on the patient¿s left side, the loss of the registration accuracy was confirmed during the case.It was also confirmed during the case that the head holder was incorrectly tightened.The incorrect fixation of the head holder fixation can generate risk of movement.The verification of the head fixation is an instruction of the ifu.The inaccuracy at the target point is confirmed per analysis.Udi# : (b)(4).

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 15436113
• MDR Text Key: 306273419
• Report Number: 3009185973-2022-00039
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE 3.1
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.6.90
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1