inforMED
MalfunctionFBJ

KARL STORZ

Received Oct 28, 2003 · Event occurred Aug 25, 2003

Report 2020550-2003-00023 · MDR key 493841

Device

Generic name

High Frequency Cord

Model number

277KB

Catalog number

277KB

Lot number

KI

Product problems

  • Replace
  • Tip breakage
  • Arcing

Patient

30 YR

  • Burn(s)
  • Surgical procedure aborted/stopped

Narrative

Description of Event or Problem

DURING A HYSTEROSCOPY ENDOMETRIAL ABLATION PROCEDURE, A KARL STORZ HIGH FREQUENCY CORD ALLEGEDLY ARCED AND SNAPPED OFF AT THE INSTRUMENT END. THE FREE END OF THE CORD SWUNG AGAINST THE PT'S LABIA MAJORA ALLEGEDLY CAUSING 2 X 1-2MM BURNS. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT CORD WITH NO FURTHER PROBLEMS.