MalfunctionFJL
SHEATH/SCOPE
Received Aug 14, 2024 · Event occurred Aug 8, 2024
Report MW5158447 · MDR key 19994644
Device
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT HAD "TRANSURETHRAL INCISION BLADDER NECK WITH MITOMYCIN INJECTION". DURING THE PROCEDURE DOCTOR IDENTIFIED THE CERAMIC TIP HAD BROKEN OFF AND WAS IDENTIFIED IN THE BLADDER. THE BROKEN ITEM WAS REMOVED BY DOCTOR AND OR MANAGER WAS NOTIFIED. DOCTOR VIEWED THE REMOVED CERAMIC TIP WITH THE ORIGINAL PART AND DETERMINED IT WAS COMPLETE. NO EVIDENCE OF ANY OTHER FOREIGN OBJECT WAS IDENTIFIED BY DOCTOR THE BLADDER WAS IRRIGATED AND DRAINED PRIOR TO CASE COMPLETE.