Device product
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Z-1906-2020
Product summary
- Event
- Event 83503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1818 pouches
- Official record key
device-enforcement:Z-1906-2020
Official wording
Reason: The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Code information: Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots
Distribution pattern: Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea
Derived failure modes
-
Sterility assurance
breach in the sterile barrier