EXABLATE PROSTATE SYSTEM
Received Mar 23, 2023 · Event occurred Jan 26, 2023
Report 9615058-2023-00008 · MDR key 16596621
Device
Generic name
Mr Guided Focused Ultrasound System
Manufacturer
Insightec Ltd.Model number
2100V1Catalog number
SYS900356
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
73 YR · Male
- Hematuria
- Hematuria
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT INCLUDES A KNOWN SIDE EFFECT FOR ABLATION OF PROSTATE TISSUE. NO NEW RISKS WERE IDENTIFIED. NO MALFUNCTION RELATED TO THE ADVERSE EVENT WAS DETECTED. SIDE EFFECTS FROM THE TREATMENT HAVE RESOLVED, AND THEREFORE THIS IS A TRANSIENT EVENT.
Description of Event or Problem
BLOOD IN URINE FOLLOWING TREATMENT FOR ABLATION OF PROSTATE TISSUE.
Additional Manufacturer Narrative
THIS COMPLAINT INCLUDES KNOWN SIDE EFFECT FOR ABLATION OF PROSTATE TISSUE. NO NEW RISKS WERE IDENTIFIED. NO MALFUNCTION RELATED TO THE ADVERSE EVENT WAS DETECTED.
Description of Event or Problem
BLOOD IN URINE FOLLOWING TREATMENT FOR ABLATION OF PROSTATE TISSUE.