Device 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.
Z-2105-2012
Product summary
- Event
- Event 62553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92390 total instrument Drapes
- Official record key
device-enforcement:Z-2105-2012
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: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
Derived failure modes
-
Unknown
Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.