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Health product recall

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

  1. da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors
  2. 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