Da Vinci Xi Surgical System - Breakage of input disks of Endowrist instruments Reprocessing Instruction: 551708-01 의 리콜

Recall

RC-2015-RN-00560-1

Class II

2015-07-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00560-1

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.

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.