inforMED
MalfunctionFAS

HF-CABLE, BIPOLAR

Received Jun 2, 2026

Report 9610773-2026-04212 · MDR key 25359433

Device

Generic name

Electrical-only Medical Device Connection Cable, Reusable

Model number

WA00014A

Product problems

  • Break
  • Sparking

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED SPARKING AT THE BIPOLAR CABLES, AND THE CABLE BROKE OFF DURING PROCEDURE INVOLVING AN OLYMPUS ELECTRICAL ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE. THERE WAS NO PATIENT INJURY REPORTED.