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Hemo-o-lock & endowrist clip applier

Official notice

11 Jul 2022

Last checked

11 Jul 2022

High riskHealth Canada
Watch Intuitive Surgical

An official Health Canada notice concerns Hemo-o-lock & endowrist clip applier. Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da vinci s/si and x/xi Endowrist clip applier instruments. Intuitive has received several complaints on the issue, which indicated non intuitive motion during an attempt to close the grips of the instrument and place a clip. Recall start date: July 1, 2022 Published 2022-07-11.

What to do now

If instruments cannot be manipulated in a precise and controlled manner, return it to manufacturer.

Recall number

64345

Official notice

2022-07-11

The hazard

Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da vinci s/si and x/xi Endowrist clip applier instruments. Intuitive has received several complaints on the issue, which indicated non intuitive motion during an attempt to close the grips of the instrument and place a clip. Recall start date: July 1, 2022

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

64345

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Affected products

Product 1

Affected products - Large Hem-O-Lock Clip Applier, Lot or serial number - All lots., Model or catalog number - 420230

Product 2

Affected products - Endowrist Medium-Large Clip Applier, Lot or serial number - All lots., Model or catalog number - 420327

Product 3

Affected products - Small Clip Applier, Lot or serial number - All lots., Model or catalog number - 420003

Product 4

Affected products - Clip Applier, Lot or serial number - All lots., Model or catalog number - 470230, 470327, 470401

Risk / hazard

Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da vinci s/si and x/xi Endowrist clip applier instruments. Intuitive has received several complaints on the issue, which indicated non intuitive motion during an attempt to close the grips of the instrument and place a clip. Recall start date: July 1, 2022

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Intuitive Surgical, Hemo-o-lock Endowrist Clip Applier

Manufacturer

Not provided

Phone

Not provided

Brand: Intuitive Surgical, Hemo-o-lock Endowrist Clip Applier.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

64345

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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