VECTRA GENISYS LASER
Received Jun 5, 2009 · Event occurred Apr 1, 2009
Report 1022819-2009-00144 · MDR key 1404660
Device
Product problems
- Component(s), overheating of
Patient
27 YR
- Blister(s)
- Burn, Thermal
Narrative
Description of Event or Problem
THE PT WAS BEING TREATED WITH LASER FOR MUSCLE SPASMS AND INFLAMMATION TO THE BILATERAL TRAPS WHEN THEY RECEIVED A SKIN BLISTER. THE DOSAGE WAS SET TO 7.5 J-CM SQUARED FOR 1.44 MINUTES OF TREATMENT. THERE WAS NO PROTECTIVE BARRIER BETWEEN THE SKIN AND THE APPLICATION. THE APPLICATOR WAS SLIGHTLY ABOVE AND IN SOME CASES TOUCHING THE SKIN. DURING THE TREATMENT, THE PT DID COMPLAIN THAT THE APPLICATOR WAS HOT AT TIMES. AFTER THE TREATMENT, SEVERAL BLISTERS OCCURRED ON BOTH SIDES OF THE TRAPS. THE BLISTERS WERE LESS THAN AN INCH IN SIZE. THE PT DID NOT SEEK MEDICAL ATTENTION OR MEDICATION FOR THE INJURY.
Additional Manufacturer Narrative
A DEVICE EVAL WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNK BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. CONCLUSION: UNIT PASSED ALL TEST CONDUCTED, NO ANOMALIES WERE FOUND. CHECKING UNIT WITH THE LASER APPLICATOR THE UNIT AND APPLICATOR OUTPUT WAS 1.34W'S. THE UNIT MEETS ALL MANUFACTURES SPECIFICATIONS.