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

Model Number ROSA 2.5.8

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device (b)(4) 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 battery replacement part of the preventive maintenance, the distributor noticed that the calibration data was not filled.

Manufacturer Narrative

It was reported that when the technician replaced the robot arm batteries he noticed that the robot arm calibration information was missing.The battery replacement should be performed once a year, otherwise the robot arm calibration information is lost and the robot arm has to be recalibrated.On this occasion device (b)(4) robot arm batteries replacement was not performed since two years.It is therefore normal that the arm calibration information was lost.Batteries were replaced and the robot arm was recalibrated.

Manufacturer Narrative

During the review of the subject complaint file, it was noted that the manufacturing date for device (b)(4) was incorrectly entered.

• 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; 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: 7047905
• MDR Text Key: 93446931
• Report Number: 3009185973-2017-00803
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK01791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• 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?: No
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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