inforMED
MalfunctionNEY

INTELLIBLATE XIMITRY PROBE ASSEMBLY, 13G X 15CM

Received Jun 9, 2025 · Event occurred May 30, 2025

Report 22167328 · MDR key 22167328

Device

Generic name

System, Ablation, Microwave And Accessories

Model number

IB-XPA-1315

Catalog number

IB-XPA-1315

Lot number

31815

Product problems

  • Break
  • Entrapment of Device

Patient

61 YR · Female

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

OCCURRED DURING MICROWAVE ABLATION OF LIVER. INTELLIBLATE NEEDLE TIP BROKE OFF DURING NEEDLE REMOVAL AFTER ABLATION WAS COMPLETED. THE NEEDLE TIP WAS IN THE LIVER TUMOR AND WAS UNABLE TO BE REMOVED.