Device 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.
Z-2101-2012
Product summary
- Event
- Event 62553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92390 total instrument Drapes
- Official record key
device-enforcement:Z-2101-2012
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: 420015-03; Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955. EXPANDED - added lot DA121075.
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.