CUTTING LOOP, BIPOLAR, F/USE W/26053EB
Received Jul 16, 2026 · Event occurred Jun 30, 2026
Report 9610617-2026-01662 · MDR key 25849901
Device
Generic name
Cutting Loop, Bipolar, F/use W/26053eb
Manufacturer
Karl Storz Se & Co. KgModel number
011050-01Catalog number
011050-01
Product problems
- Overheating of Device
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "THE RESECTION LOOP BECAME BURNT/MELTED DURING INTRAUTERINE USE. SIGNIFICANT DAMAGE WAS OBSERVED TO THE INNER SHEATH AND OPTICAL COMPONENT. THE PROCEDURE WAS STOPPED IMMEDIATELY, AND THE EQUIPMENT WAS REPLACED." FURTHERMORE, THE EVENT RESULTED IN AN ENDOMETRIAL BURN.