ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR
Received Dec 5, 2024 · Event occurred Nov 12, 2024
Report 9610617-2024-00494 · MDR key 20857652
Device
Generic name
Electrode, Bipolar
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
011168-10Catalog number
011168-10
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. 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 LOOP OVERHEATED DURING SURGERY AND WAS THEREFORE CHANGED. THE SPARE DEVICE HAS ALSO OVERHEATED AND THEN BROKE IN THE PATIENT´S BLADDER. NO ADVERSE CONSEQUENCES OCCURRED. THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY.