Stainless Steel Reprocessing Tray, 8mm Endoscope, IS4000 and 2D Camera Head, IS4000 (2019-12-19)
- Starting date:
- December 19, 2019
- Posting date:
- January 10, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72083
Last updated: 2020-01-10
Affected Products
- Stainless Steel Reprocessing Tray, 8mm Endoscope, IS4000
- Stainless Steel Reprocessing Tray, 2D Camera Head, IS4000
Reason
Intuitive has become aware of, via field complaints, the potential for small, but detectable holes to be generated in the sterilization wrap used with Da Vinci 8 mm endoscope sterilization trays (PN 400498-02) and handheld camera sterilization trays (PN 400499-03) which could lead to a breach in sterility.
Affected products
-
Stainless Steel Reprocessing Tray, 8mm Endoscope, IS4000
Lot or serial number
All lots.
Model or catalog number
400498-02
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
California
UNITED STATES
B. Stainless Steel Reprocessing Tray, 2D Camera Head, IS4000
Lot or serial number
All lots.
Model or catalog number
400499-03
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
California
UNITED STATES