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 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

The device (b)(4) has been inspected for investigation purpose.The tests performed confirmed that the fixation process steps of the mayfield adaptor was not properly followed and damaged the fixation of the adapter on the support arm.The damaged components were replaced for repair purpose.The internal complaint reference is the following: (b)(4).

Event Description

It has been reported that during a surgery, the mayfield adapter was hard to screw and the fixation was not correct.No patient impact has been reported.

• 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 ; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000 ; 7414400
• MDR Report Key: 6456809
• MDR Text Key: 71628446
• Report Number: 3009185973-2017-00470
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA 2.5.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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