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

Model Number ROSA ONE

Device Problem Positioning Failure (1158)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Few elements of the dhr were reviewed for the investigation.The last preventive maintenance, performed on the 02-apr-2021 passed.A full analysis of the data logs and of the patient folder has been performed.This analysis concluded that although the registration was performed properly, the inaccuracy is confirmed for all twelve electrodes implanted.The deviation analysis shows that the electrodes were all deviated in the same direction which could be caused by one or multiple undetected head movements.The review of the case with the surgeon permitted to determined that although the mayfield system was properly locked before the case, it is possible that the pins stabilization failed during the surgery.Indeed, it is suspected that two pins among three were not properly implanted in the skull which would allow head movements during the holes drilling.No failure of the rosa one device was detected through investigation.Based on the investigation performed, the technical root cause of the event was suspected to be a head shift due to the mayfield head holder pins incorrectly implanted.Unique identifier (udi) #: (b)(4).

Event Description

It was reported that the company representative (cr) assisted the surgeon for an seeg case using (b)(4).After the case was concluded, a post-op ct was obtained and merged to the plan.The cr noticed that most of the electrodes appeared to be inaccurately placed, with the error being anywhere between 4-6mm off at entry/target.The cr did not notice any head shift during the case, and the merge of the postop appeared to be correct.Contactless registration was used, and all verification points passed.The post-op scan was obtained after surgery, so there was no delay to the case, and the patient was no longer under anesthesia.

• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12312594
• MDR Text Key: 266204677
• Report Number: 3009185973-2021-00176
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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