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

Model Number ROSA 2.5.8

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

At the beginning of the surgery, while installing the mayfield head holder adapter on the device surgeon found a lot of resistance from one of its screws.However surgeon was able to position this part appropriately to perform surgical procedure.At the end of the surgical procedure, the mayfield head holder adapter was disassembled and it was noticed that the screw and corresponding screw threads were damaged.

Manufacturer Narrative

User error during the tightening of the screw could be the root cause of the defect.If the two parts of the support arm rosa-256-e (se6 and se7) are not correctly aligned during installation.It is possible to damage the thread and the screw during tightening.

• 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: elise lagacherie ; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000 ; 467107740
• MDR Report Key: 6352847
• MDR Text Key: 68231962
• Report Number: 3009185973-2017-00016
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1