SONABLATE
Received Sep 9, 2024
Report 2951226-2024-00007 · MDR key 20176511
Device
Generic name
High Intensity Ultrasound System For Prostate Tissue Ablation
Manufacturer
Focus Surgery, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Urinary Retention
- Urinary Retention
Narrative
Additional Manufacturer Narrative
PATIENTS ARE AT RISK FOR URINARY RETENTION POST HIFU. IF THE PATIENT HAS THE INABILITY TO URINATE WITH A URINARY CATHETER IN PLACE, THE CATHETER SHOULD BE CHECKED FOR OBSTRUCTION. IF THE OBSTRUCTION CANNOT BE RESOLVED THE PATIENT WILL NEED TO GO TO HIS DOCTOR OR THE EMERGENCY ROOM TO HAVE THE CATHETER FLUSHED. THE INABILITY TO URINATE IS LESS COMMON POST CATHETER REMOVAL.
Description of Event or Problem
ON (B)(6) 2024, THE MANUFACTURE RECEIVED A CONCERN FROM THE PHYSICIAN THAT THE PATIENT TREATED 3 WEEKS PRIOR IS EXPERIENCING URINARY RETENTION, PROSTATE/RECTAL PAIN, AND CONSTIPATION. THERE IS NOT YET ENOUGH INFORMATION TO DETERMINE THE SEVERITY OF THE SYMPTOMS, NEVERTHELESS OUT OF CAUTION THIS REPORT IN BEING SUBMITTED. THE MANUFACTURER HAD REQUESTED ADDITIONAL INFORMATION AND ACCESS TO THE DEVICE TO CONDUCT FURTHER INVESTIGATION. AT THIS TIME IT WAS INDICATED THAT A FLEXIBLE SCOPE WAS PLANNED FOR THE PATIENT.