inforMED
InjuryDWQ

CODMAN DISPOSABLE VEIN STRIPPER

Received Dec 31, 1996 · Event occurred Jun 25, 1996

Report 65212 · MDR key 65212

Device

Generic name

Vein Stripper

Model number

63-4031

Catalog number

*

Lot number

2KM480

Product problems

  • Tip breakage

Patient

38 YR

  • Surgery, prolonged
  • Foreign body, removal of

Narrative

Description of Event or Problem

DURING VASCULAR SURGERY PROCEDURE THE STRIPPER OLIVE ON THE VEIN STRIPPER BROKE OFF FROM THE STRIPPER CABLE AND BECAME LOOSE IN THE PT'S THIGH. FLOUROSCOPY AND INCISION WERE NECESSARY TO REMOVE THE OLIVE. THIS IS THE SECOND TIME THIS HAS OCCURRED WITH THIS PRODUCT. BOTH EVENTS INVOLVED THE SMALL OLIVE BECOMING LOOSE.