inforMED
MalfunctionFAS

ELECTRODE, UNIPOLAR, ANGLED

Received May 22, 2026

Report 9610617-2026-01163 · MDR key 25259910

Device

Generic name

Electrode, Unipolar, Angled

Model number

011110-10

Catalog number

011110-10

Lot number

861896

Product problems

  • Break

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

THE EVENT OCCURRED IN CANADA. ACCORDING TO THE INFORMATION RECEIVED, THE INSULATED PART BROKE AND BURNED 2 SCOPES. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.