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

Model Number ROSA ONE

Device Problem Unintended Collision (1429)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The subject complaint is being opened in relation from a comment made by a surgeon as part of the customer satisfaction survey 2021, stating that 'there should be an auto collision detection feature (helps with some complex seeg cases).There is no further information available about this event currently.

Event Description

The subject complaint is being opened in relation from a comment made by a surgeon as part of the customer satisfaction survey 2021, stating that 'there should be an auto collision detection feature (helps with some complex seeg cases).' there is no further information available about this event currently.

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.D4 unique identifier (udi) #: (b)(4).This is a full supplemental report identical to the initial report, being resubmitted due to an ack failure (duplicate error report).

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.The complaint is a design request which was submitted through the the rosa brain customer satisfaction survey 2021.No specific data or information were provided for the investigation about the collision observed during site seeg procedures.A available data on the device since oct 2018 was reviewed.These data confirms the detection of collision during surgeries.However, the number of available data is underestimated.The vigilance device is controlled by the user and must be release to prevent collisions.For this fact, the complaint can be considered as an improvement opportunity.Collisions events are also managed though software by safety procedures.H3 other text: no data available.

Event Description

The subject complaint is being opened in relation from a comment made by a surgeon as part of the customer satisfaction survey 2021, stating that 'there should be an auto collision detection feature (helps with some complex seeg cases).' there is no further information available about this event currently.

• 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: 13559679
• MDR Text Key: 288027969
• Report Number: 3009185973-2022-00013
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 01/21/2022; 07/22/2022
• Supplement Dates FDA Received: 03/03/2022; 07/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2019
• 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