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

Model Number FORCE SENSOR

Device Problem Misconnection (1399)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2017

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 testing of the device performed by a medtech representative, the force sensor cable got detached and entangled in the robot arm.The force sensor cable was not damaged but its connector was damaged.

Manufacturer Narrative

During the applicative test the field service engineer did not pay attention and the force sensor cable got entangled in the robot arm and the connection broke.The most probable root cause is a user error.

Manufacturer Narrative

This complaint is being remediated under an issue evaluation: complaints item numbers remediation.The item number was updated, the concerned medical device was the force sensor and not the rosa robot.

Event Description

During an applicative testing of the device performed by a medtech representative, the force sensor cable got detached and entangled in the robot arm.The force sensor cable was not damaged but its connector was damaged.

Event Description

During an applicative testing of the device performed by a medtech representative, the force sensor cable got detached and entangled in the robot arm.The force sensor cable was not damaged but its connector was damaged.

Manufacturer Narrative

The force sensor interface and interface block were returned for investigation on 09-nov-2021.However, the initial findings are not challenged by the investigation performed on these parts.Therefore, the most probable root cause remains a user error (during the applicative test the field service engineer did not pay attention and the force sensor cable got entangled in the robot arm and the connection broke).

• 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: 6662711
• MDR Text Key: 78259113
• Report Number: 3009185973-2017-00639
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCE SENSOR
• Device Catalogue Number: ROSAS00124
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• 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