inforMED
MalfunctionFJL

SHEATH/SCOPE

Received Aug 14, 2024 · Event occurred Aug 8, 2024

Report MW5158447 · MDR key 19994644

Device

Generic name

Resectoscope

Model number

8675324

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.