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

Model Number ROSA ONE

Device Problem Unintended Collision (1429)

Patient Problem No Code Available (3191)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

The device rosa one bs16001 is not fda approved, but it is similar to the device rosa brain 3.0, classified haw - k151359.Investigation indicated that the device computer configuration was modified but not set back to the correct configuration before device shipment to customer.

Event Description

It was reported that during a surgery, the robot arm collided with the robot stand reference.

• 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: 7016837
• MDR Text Key: 91793410
• Report Number: 3009185973-2017-00784
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• 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: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1