HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
Received Apr 8, 2026
Report 3007960282-2026-00065 · MDR key 24824103
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22702SProduct problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION: THE MOST PROBABLE CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE, EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE, AND DUE TO DEGRADATION PROBLEM IDENTIFIED, PROBLEMS THAT OCCURRED WHEN THE DEVICE BECOMES WORN, WEAKENED, CORRODED, OR BROKEN DOWN DUE TO PROCESSES SUCH AS AGING, PERMEATION, AND CORROSION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED THE CUTTING WIRE WAS BROKEN OFF/MISSING FROM THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.