inforMED
MalfunctionFAS

CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.

Received Apr 14, 2026 · Event occurred Apr 6, 2026

Report 9610617-2026-00826 · MDR key 24874710

Device

Generic name

Cutting Loop, Bipolar, 0.30mm, 24/26 Fr.

Model number

27040GP130-S

Catalog number

27040GP130-S

Lot number

43HE0539

Product problems

  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURER FOR FURTHER 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

IT WAS REPORTED THAT THE LOOP ELECTRODE BROKE OFF INSIDE THE BLADDER OF THE PATIENT. THE DOCTOR RECOVERED THE BROKEN PART AND REMOVED IT FROM THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.