da Vinci S/Si and da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors (2018-08-06)
- Starting date:
- August 6, 2018
- Posting date:
- August 17, 2018
- 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-67400
Affected products
- da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors
- da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors
Reason
Specific versions of the da Vinci S/Si and da Vinci X/Xi Monopolar Curved Scissor (MCS) instruments that may be more susceptible to developing cracks near the proximal edge of the extension tube, potentially attributed to mishandling and misuse as defined by the Instrument and Accessories User Manual. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
Affected products
A. da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors
Lot or serial number
- N10170819
- N10171002
- N10180219
- N11170306
- S10161130
Model or catalog number
420179
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
California
UNITED STATES
B. da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors
Lot or serial number
- N10160316
- N10160322
- N10161021
- N10170308
- N10170310
- N10170524
- N11160129
- N11161122
- N11170419
- N11170522
Model or catalog number
470179
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
California
UNITED STATES