Device Recall KIT,DISPOSABLE ACCESSORY 의 리콜

Recall

62553

Class 2

Z-2104-2012

2012-07-13

2012-07-27

Terminated

United States

2013-06-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110981

Specific lots of the instrument arm drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

Intuitive Surgical sent an Urgent Medical Device Correction letters dated July 16, 2012 via Fed Ex to all affected customers in the US. The customers outside of the US were notified starting July 17, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to Identify affected lots, order replacement products and return both full and partial boxes of the affected products for credit as soon as unaffected products are available. All staff should be made aware of the issue. Customers were instructed to complete and return the acknowledgement form immediately. Questions and concerns should be directed to Intuitive Customer Service at 1-800-876-1310. EXPANSION: Intuitive discovered an additional lot (Lot DA121075) of Instrument Arm Drape IS2000, 20 pack that should have been included in the recall and expanded the recall on September 4, 2012. Letters to customers were sent by Fed Ex on September 5, 2012.