ELECTRODE, UNIPOLAR, POINTED
Received Apr 14, 2025 · Event occurred Mar 18, 2025
Report 9610617-2025-00570 · MDR key 21834352
Device
Generic name
Electrode, Unipolar, Pointed
Manufacturer
Karl Storz Se & Co. KgModel number
011111-10Catalog number
011111-10
Lot number
850969
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "DURING THE PROCEDURE PART OF THE LOOP WAS DETACHED FROM ITS BODY." FURTHERMORE, IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
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).
Additional Manufacturer Narrative
AN INCORRECT ADDRESS WAS PROVIDED IN SECTION G1 IN THE INITIAL REPORT. THIS SUPPLEMENTAL REPORT IS TO PROVIDE THE CORRECT CONTACT INFORMATION FOR THIS SECTION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).