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
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
Soltive Premium Superpulsed Laser System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
TFL?PLS
Companies
- Manufacturer
-
Gyrus Acmi, Inc.
9600 LOUISIANA AVE. NORTH
BROOKLYN PARK
55445
Minnesota
UNITED STATES