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5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. ...

FDA Device Recall #Z-1334-2014 — Class II — March 13, 2014

Recall Summary

Recall Number Z-1334-2014
Classification Class II — Moderate risk
Date Initiated March 13, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Intuitive Surgical, Inc.
Location Sunnyvale, CA
Product Type Devices
Quantity 5217 total cannulae

Product Description

5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

Reason for Recall

Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.

Distribution Pattern

Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Lot / Code Information

Part number 428071-03: Lot numbers: VE113001 VE121004 VE121205 VE122004 VE122604 VE123014 VE113401 VE121007 VE121407 VE122005 VE122901 VE123107 VE114001 VE121103 VE121410 VE122104 VE122904 VE123202 VE114401 VE121105 VE121604 VE122204 VE122908 VE120602 VE121109 VE121608 VE122302 VE122911 VE120701 VE121110 VE121804 VE122403 VE123007.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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