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Recall Observatory FDA recall evidence

Device product

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

Z-2782-2015

September 09, 2015

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 72158
Status
Terminated
Classification
Class II
Quantity
1200 kits
Official record key
device-enforcement:Z-2782-2015

Official wording

Reason: B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.

Code information: Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301. Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902. Product number 950156-03: Lot numbers : NQ144001 NQ150501 NQ143902 NQ150601 NQ143901 NQ150602 NQ143803 NQ150703 NQ143601 NQ150701 NQ143602 NQ150702 NQ144502 NQ150801 NQ144801 NQ150901 NQ145202 NQ150802 NQ144901 NQ151001 NQ145301 NQ151002 NQ145201 NQ151101 NQ150301 NQ150501 NQ144001.

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in sterility