inforMED
MalfunctionFAS

ELECTRODE, BIPOLAR

Received May 26, 2026 · Event occurred Apr 24, 2026

Report 9610617-2026-01191 · MDR key 25281137

Device

Generic name

Electrode, Bipolar

Model number

011050-01

Catalog number

011050-01

Lot number

861255

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE CUSTOMER INFORMED THE SALES REPRESENTATIVE THAT THEY EXPERIENCED AN ISSUE WITH THE SIZE 15 RESECTOR ON FRIDAY, (B)(6) 2026. DURING A MEDICAL PROCEDURE, WHILE USING IT ON A PATIENT, TWO LOOP EXPLOSIONS OCCURRED. FORTUNATELY, THE PATIENT DID NOT SUFFER ANY HARM. WITH THE FIRST EXPLOSION, THE BAKELITE COMPONENT WAS NOT DAMAGED; HOWEVER, WITH THE SECOND LOOP USED (NEW), BROKE. IN ORDER TO CONTINUE WITH THE MEDICAL PROCEDURE, A THIRD LOOP WAS USED, WHICH FUNCTIONED CORRECTLY. THEREFORE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CROSS REFERENCE MDR: 9610617-2026-1190 9610617-2026-1192.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).