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Recall Observatory FDA recall evidence

Device product

ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

Z-2106-2012

July 13, 2012

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 62553
Status
Terminated
Classification
Class II
Quantity
92390 total instrument Drapes
Official record key
device-enforcement:Z-2106-2012

Official wording

Reason: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

Code information: Part number: 380595-02 Lot numbers: 298601, 298602, 298608, 298613, 298625, 298627, 298629.

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.