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

Model Number ROSA 2.5.8

Device Problems Unintended Collision (1429); Loss of Data (2903)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

It was reported that during a surgery the robotic arm collided with the device covers, generating a communication error in the system and a shutdown.When the device was restarted the registration of the patient position was not accurate anymore.This event occurred right before implanting the last electrode, for that reason the surgeon decided not to implant it.

Manufacturer Narrative

The device (b)(4) has not been inspected for investigation purpose.Analysis of data log files form the subject event for investigation purpose determined that the patient head was too close to the robot during the surgery.The ifu was reviewed for investigation purpose, this review indicated that the most probable root cause is insufficient information in the ifu regarding the recommended distance between patient¿s head and the robot.Corrected data: date received by manufacturer.Visual and functional inspection.

Manufacturer Narrative

The delay occurred during the surgery was 30 mins.(b)(4),.

• Brand Name: ROSA SURGICAL DEVICE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; 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: 6743203
• MDR Text Key: 81002591
• Report Number: 3009185973-2017-00670
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA 2.5.8
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2011
• 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