Soltive Premium Superpulsed Laser System (2021-06-22)

Starting date:

June 22, 2021

Posting date:

June 30, 2021

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-75943

Last updated:
2021-06-30

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  Reason
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  Affected products

Affected Products 

Soltive Premium Superpulsed Laser System

Reason

The manufacturer, Gyrus Acmi Inc., received complaints about loss of kidney function after lithotripsy procedures involving the subject device. Through a clinical investigation and consultation with medical professionals, the events were potentially the result of knowledge-based failure where the user accustomed to using a different laser (Holmium:YAG) applied more energy than needed to achieve a certain outcome with the Soltive laser. Prior to these reported events, Olympus had planned for a software upgrade containing a new preset for ureteral stone. In light of this investigation, Olympus will expedite the distribution of the software upgrade as a preventative

measure. Additionally, the instruction for use will be updated to include additional verbiage regarding procedural differences between Holmium:YAG lasers and soltive lasers as it relates to device settings.

Affected products