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 Patient Involvement (2645)

Event Date 12/12/2014

Event Type  malfunction  

Manufacturer Narrative

The device ro09004 has been inspected for investigation purposes.The inspection confirmed that the sheath needed to be replaced.The defective parts were replaced for repair purposes.

Event Description

During an intervention performed on customer site by our field engineer, it was identified that the force sensor cable was non-functional.There was no patient involvement 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, 34000 ; FR 34000
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; zac eureka; 900 rue du mas de verchant; montpellier, 34000 ; FR 34000 ; 7414400
• MDR Report Key: 6456860
• MDR Text Key: 71624712
• Report Number: 3009185973-2017-00417
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• 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

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ROSA 2.5.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: Reuse
• Patient Sequence Number: 1