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

Agency Publication Date: July 27, 2012

Affected Products

Product: INSTRUMENT ARM DRAPE IS2000, 20 PACK: 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.

Part number: 420015-03; Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955. EXPANDED - added lot DA121075.

Lot Numbers:

numbers

DA121075

Product: KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; 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.

Part number: 420256-01 Lot numbers: D120745, D120755, D120835, D120865.

Lot Numbers:

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Product: KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; 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.

Part number: 420258-01 Lot numbers: D120755 ,D120755A , D120825.

Lot Numbers:

numbers

Product: KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; 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.

Part number: 420290-03 Lot numbers: D120735,,D120745,D120815, D120815A, D120885, D120895, D120905 D120945, D120955, D120955A, D120965, D121025, D121035, D121045, D121075, D121075A, D121095, D121155, D121165, D121165A, D121215.

Lot Numbers:

numbers

Product: KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; 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.

Part number: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A

Lot Numbers:

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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.

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

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62553

Status: Resolved

Manufacturer: Intuitive Surgical, Inc.

Manufactured In: United States

Units Affected: 6 products (92390 total instrument Drapes)

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Sources: FDA iRES · Raw API Response

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Affected Products

Part number: 420015-03; Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955. EXPANDED - added lot DA121075.

Lot Numbers:

numbers

DA121075

Part number: 420256-01 Lot numbers: D120745, D120755, D120835, D120865.

Lot Numbers:

numbers

Part number: 420258-01 Lot numbers: D120755 ,D120755A , D120825.

Lot Numbers:

numbers

Lot Numbers:

numbers

Part number: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A

Lot Numbers:

numbers

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

Lot Numbers:

numbers