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

Model Number N/A

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

The optical distance sensor of ro10011 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

During device routine maintenance performed by a medtech field service engineer, the optical distance sensor failed the accuracy checks.

Manufacturer Narrative

The distance sensor was inspected and it was pointed out that it was manufactured according to a previous version of drawing, that use a circular hole for the pin.The design has since evolved and now uses an oblong hole for the pin to avoid similar incident and facilitate the mounting of instruments on the interface block.

• 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; 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: 6547529
• MDR Text Key: 74592345
• Report Number: 3009185973-2017-00606
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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