FDA Adverse Event Injury Summary report: N

YAG LASER

MDR report key: 652075 · Received November 29, 2005

Report

Report Number
652075
Event Type
Injury
Date Received
November 29, 2005
Date of Event
October 29, 2005
Report Date
November 29, 2005
Manufacturer
OMNIGUIDE, INC
Product Code
GEX
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

A PATIENT WITH METASTATIC LUNG CANCER TREATED PREVIOUSLY USING YAG LASER AND WAS SUCCESSFUL.IN THIS EVENT, THE PATIENT HAD LUNG RESECTION WITH THE YAG LASER THAT APPEARED TO GO WELL. IN RECOVERY ROOM, IT BECAME APPARENT THAT PATIENT WAS WAKING SLOWLY, COULD NOT SPEAK AND COULD NOT MOVE EXTREMITIES X4. MULTIPLE MRIS AND CT SCANS SHOWED NO BLEEDING AND LIMITED STROKE. MRI REPORT STATED "CONFUSING PICTURE CONSISTING OF ABNORMAL SIGNAL INTENSITY ON DIFFUSION-WEIGHTED IMAGES IN WATERSHED REGIONS ON HIGH CONVEXITY SECTIONS, AS WELL AS HYPERINTENSITY OF SULCI ON FLAIR IMAGES. FAIRLY NORMAL ARTERIAL CIRCULATION NOTED. THE RIGHT VERTEBRAL ARTERY IS QUITE SMALL. THE ABOVE FINDINGS CAN BE SEEN IN PATIENTS WHO HAVE SUFFERED HYPOPERFUSION, FOR EXAMPLE, AS A RESULT OF SUDDEN HYPOTENSION. SIGNAL ABNORMALITY OF SUBARACHNOID SULCI MAY REPRESENT THE EFFECT OF TREATMENT WITH PURE OXYGEN". THE CLINICAL DIAGNOSIS WAS AIR EMBOLISM WHICH RESOLVED RELATIVELY RAPIDLY. THE PATIENT'S HOSPITALIZATION WAS EXTENDED APPROXIMATELY ONE WEEK, BY THE END OF WHICH HIS SYMPTOMS NEARLY COMPLETELY RESOLVED. ON TRANSFER TO REHAB PATIENT HAD SLIGHT WEAKNESS IN RIGHT LEG, BUT CAN AMBULATE WITH CANE. NEUROLOGY IS OPTOMISTIC FOR FULL RECOVERY. THE SURGEON BELIEVES A GAS EMBOLISM IS A LIKELY EXPLANATION DUE TO HIGHLY VASCULAR TUMOR, WITH INCREASED BLEEDING, AND THE PROCEDURE TOOK A RELATIVELY LONG TIME TO COMPLETE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 YAG LASER CO2 LASER GEX OMNIGUIDE, INC 800 *

Patients

Seq Age Sex Outcome Treatment
1 * Hospitalization| R| S