CUTTING LOOP, BIPOLAR, 24/26 FR.
Received Mar 11, 2026 · Event occurred Mar 2, 2026
Report 9610617-2026-00525 · MDR key 24570650
Device
Generic name
Cutting Loop, Bipolar, 24/26 Fr.
Manufacturer
Karl Storz Se & Co. KgModel number
27040GP1-SCatalog number
27040GP1-S
Lot number
37BE1854
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OUR US FACILITY ON MARCH 11, 2026. IT WILL BE FORWARDED TO THE MANUFACTURING SITE FOR 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). CROSS REFERENCE INTERAL COMPLAINT ID (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SURGEON WAS USING OUR 27040GP1-S BIPOLAR LOOP FOR A TURP PROCEDURE AND 30 MINUTES INTO THE CASE THE LOOP CAME APART AND BASICALLY SPLIT IN HALF. THE LOOP WAS BRAND NEW RIGHT OUT OF THE STERILE PACKAGING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. 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). CROSS REFERENCE INTERAL COMPLAINT ID (B)(4).