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

Model Number ROSA 2.5.8

Device Problem Misconnection (1399)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2017

Event Type  malfunction  

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

During an applicative test the arm drifted without anybody touching it.The customer replugged the force sensor cable.Afterwards he did several tests without any drifting.The issue was probably due to a lost contact in the force sensor controller, because the cables were exchanged on (b)(6) 2017.

Manufacturer Narrative

The force sensor controller from device (b)(4) was returned to the manufacturer and has been inspected for investigation purpose.It was identified through functional testing on a similar rosa surgical device that this component was defective, and that this is the root cause for the drift reported in this complaint.Based on the available information, it was not possible to determine why the force sensor controller is defective.A new force sensor controller was installed on device (b)(4).

Event Description

During an applicative test the arm drifted without anybody touching it.The medtech representative re-plugged the force sensor cable afterwards he did several tests without any drifting.The issue was probably due to a lost contact in the force sensor controller, because the cables were exchanged on 21-apr-2017.

• Brand Name: ROSA SURGICAL
• 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: 6649635
• MDR Text Key: 77845038
• Report Number: 3009185973-2017-00637
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• 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: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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