CUTTING LOOP, BIPOLAR, 24/26 FR.
Received Jul 20, 2026 · Event occurred Jul 3, 2026
Report 9610617-2026-01672 · MDR key 25876317
Device
Generic name
Cutting Loop, Bipolar, 24/26 Fr.
Manufacturer
Karl Storz Se & Co. KgModel number
27040GPO1Catalog number
27040GPO1
Lot number
UK04
Product problems
- Retraction Problem
Patient
Not reported
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT WHEN ATTEMPTING TO RETRACT THE ELECTRODE INTO THE INNER SHEATH, IT GOT CAUGHT ON THE EDGE AND BECAME STUCK. THE OPERATOR WAS FORCED TO WITHDRAW THE ENTIRE INSTRUMENT WITH THE ELECTRODE SCRAPING AGAINST THE URETHRA. CONSEQUENTLY, A CATHETER HAD TO BE INSTALLED IN THE PATIENT.