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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00560-1
Product Name/Description Da Vinci Xi Surgical System - Breakage of input disks of Endowrist instruments

Reprocessing Instruction: 551708-01

ARTG Number: 97348
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/07/2015
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue The manufacturer, Intuitive Surgical Inc, has determined that the use of the Getinge 88 Turbo Washer/Disinfector in combination with Getinge Clean MIS to reprocess instruments results in a higher chance of input disk breakage, rendering the instrument inoperable. The appendices in the reprocessing manuals incorrectly list the Getinge 88 Turbo Washer/Disinfector and the Getinge Clean MIS combination for reprocessing instruments. The Getinge combination of equipment and cleaning agents leaves a residual amount of detergent on the input disks resulting in disk breakage during sterilisation.
Recall Action Recall for Product Correction
Recall Action Instructions Device Technologies Australia (DTA) is requesting the customers to discontinue the use of the Getinge 88 Turbo Washer/Disinfector with Getinge Clean MIS for reprocessing da Vinci Xi instruments. DTA is suggesting alternative reprocessing methods. DTA is also instructing the customers to inspect the input disks of the Endowrist Instruments and identify any broken disks. Device Technologies representative will contact the customer to arrange the returns. This action has been closed-out on 10/08/2016.
Contact Information 07 3623 1400 - Product Manager