inforMED
MalfunctionFAS

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

Received Mar 26, 2026 · Event occurred Mar 17, 2026

Report 9610617-2026-00665 · MDR key 24702376

Device

Generic name

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

Model number

27040GP130-S

Catalog number

27040GP130-S

Lot number

43GE9446

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 LOOP BROKE OFF INSIDE THE PATIENT. THE LOOP COULD BE REMOVED BY THE SURGEON, BUT THE REMOVAL REQUIRED ADDITIONAL SURGICAL TIME. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.