inforMED
InjuryFBO

KARL STORZ

Received Jul 1, 2019 · Event occurred Jun 11, 2019

Report 8770942 · MDR key 8770942

Device

Generic name

Thin Pedi System

Model number

27033

Catalog number

17114-000

Lot number

STZPDICYS-000

Product problems

  • Fluid/Blood Leak
  • Inflation Problem
  • Fluid/Blood Leak
  • Inflation Problem

Patient

25 YR

  • Scar Excision
  • Scar Excision

Narrative

Description of Event or Problem

THE NIPPLE THAT CONTROLS FLUID FROM EXITING THE SCOPE WAS MISSING AND THE SURGEON COULD NOT MAINTAIN THE PRESSURE. SURGEON HAD TO INSERT AND REMOVE THE SCOPE SEVERAL TIMES TO TROUBLESHOOT THE PROBLEM. DURING THIS REMOVAL AND INSERTION, A URETHRAL TEAR WAS CREATED.