PlainRecalls
FDA Devices Moderate Class II Terminated

Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.

Reported: June 11, 2014 Initiated: May 9, 2014 #Z-1718-2014

Product Description

Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.

Reason for Recall

Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
2
Distribution
Medical facilities in TX and FL
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled? ▼
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.. Recalled by Intuitive Surgical, Inc.. Units affected: 2.
Why was this product recalled? ▼
Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2014. Severity: Moderate. Recall number: Z-1718-2014.

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