SONABLATE
Received May 2, 2019 · Event occurred Feb 17, 2017
Report 2951226-2017-00001 · MDR key 8575024
Device
Generic name
High Intensity Focused Ultrasound Device
Manufacturer
Focus Surgery, IncModel number
SONABLATEProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Diarrhea
- Fistula
- Constipation
- Diarrhea
- Fistula
- Constipation
Narrative
Description of Event or Problem
THE PATIENT HAD A WHOLE GLAND ABLATION IN FEBRUARY POST OP HE WAS VERY CONSTIPATED FOR ONE WEEK TREATED WITH ORAL MEDICATION HAD DIARRHEA FOR FEW WEEKS NO RECTAL SUPPOSITORY OR ENEMA WAS USED HE COMPLAINED THE FOURTH WEEK POST OP OF REGULAR BOWL MOVEMENT BUT A TEASPOON OF CLEAR LIQUID DRAINAGE AFTER THE BOWL MOVEMENT CYSTOGRAM SHOWED SMALL RECTAL FISTULA. PATIENT WAS REFERRED TO USC FOR REPAIR AS CONSERVATIVE S/P DRAINAGE DID NOT CLOSE THE FISTULA" AND AGAIN AFTER ANOTHER FOLLOW UP THE FOLLOWING RESPONSE WAS RECEIVED FROM THE PHYSICIAN: "PROCEDURE WAS DONE ON 17 FEBRUARY I BELIEVE HIS CONSTIPATION AND STRAINING TO STOOL AND VOID COULD HAVE CONTRIBUTED TO THE FISTULA PLEASE REVIEW CASE AND LET ME KNOW.