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Health product recall

Da Vinci S Surgical System- Endoscopic Instrumentation, Large HEM-O-LOK clip applier and Large HEM-O-LOK clip applier (2014-06-13)

Starting date:
June 13, 2014
Posting date:
July 3, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40259

Recalled Products

A) Da Vinci S Surgical System- Endoscopic Instrumentation
B) Da Vinci S Surgical System - Large HEM-O-LOK clip applier
C) Large HEM-O-LOK clip applier

Reason

Recall due to manufacturing variation in the grip assembly of the instrument which can lead to the instrument jamming during insertion when used with the 8mm cannula or with certain cannula reducer accessories.

Affected products

A) Da Vinci S Surgical System- Endoscopic Instrumentation

Lot or serial number

All lots contact manufacturer.

Model or catalog number

420230

Companies
Manufacturer
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES

B) Da Vinci S Surgical System - Large HEM-O-LOK clip applier
 

Lot or serial number

All lots contact manufacturer.

Model or catalog number

420230

Companies
Manufacturer
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES

C) Large HEM-O-LOK clip applier

Lot or serial number

All lots contact manufacturer.

Model or catalog number

420230

Companies
Manufacturer
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES