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

Model Number COMPUTER FOR PRE OP PLANNING

Device Problem Loss of Data (2903)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2018

Event Type  malfunction  

Manufacturer Narrative

The planning station from device (b)(6) 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 planning station used for pre-operative planning did not store the images that were loaded.

Manufacturer Narrative

It was reported by the surgeon that data was lost on the computer for pre op planning.Software analysis was performed and identified that a software crash occurred 2 times.The first crash was design related and the images were not saved.The images were later saved without issue.A second crash occurred after the computer was not correctly shutdown, however this did not result in the loss of any data.

• 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
• MDR Report Key: 7204983
• MDR Text Key: 97724712
• Report Number: 3009185973-2018-00019
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMPUTER FOR PRE OP PLANNING
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1