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

Model Number ROSA 2.5.8

Device Problems Bent (1059); Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2018

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

It was reported that the power input connector is bent due to long-term-use effort applied via the power cable.The monitor is still functional, but depending on the position of the touchscreen, there are some powering off/up issues.

Manufacturer Narrative

Following the investigation, the root cause of the bent of the power input connector is wear due to long-term-use effort applied via the power cable.Corrected data: date of this report, date received by manufacturer, if follow-up, what type, device evaluated by manufacturer, evaluation code, remedial action.

• 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: 7214628
• MDR Text Key: 98046499
• Report Number: 3009185973-2018-00024
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1