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

Model Number ROSA

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

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 a rubber foot on hydraulic stabilization system fell off during transport of the device between hospitals.A foreign rubber piece was placed under the metal foot to ensure stability.The surgeon and staff were made aware of the adjustment and chose to move forward with the surgery.

Manufacturer Narrative

The investigation found that this is the second occurrence of a missing rubber base from the immobilization feet of the device.The detachment of the rubber component of the hydraulic foot occurred during transfer of the device from one hospital department to another by the customer.A capa related to failures of the hydraulic stabilisation system is currently in progress.The defective part was removed and replaced with a functioning part for repair purposes.

• 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: 7120793
• MDR Text Key: 95771631
• Report Number: 3009185973-2017-00828
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

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: Medical Equipment Company Technician/Representative
• Device Model Number: ROSA
• Device Catalogue Number: N/A
• Device Lot Number: 2.5.8.07
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2015
• 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