inforMED
MalfunctionFAS

ELECTRODE, BIPOLAR

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

Report 9610617-2026-01190 · MDR key 25281052

Device

Generic name

Electrode, Bipolar

Model number

011050-10

Catalog number

011050-10

Lot number

861255

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

CORRECTIONS ARE MADE IN SECTION G3, AND H6. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

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).

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: 9610617-2026-1191 9610617-2026-1192.