HF COMBI UNIT 300W MONOP.80W.BIPOLAR
Received Mar 27, 2017
Report 9610612-2017-00151 · MDR key 6437603
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE SENT THE DEVICE TO THE GENERATOR MANUFACTURING FOR ANALYSIS. THEY TESTED THE DEVICE AT THE END OF LINE TEST AND COMPARED THE RESULTS WITH THE ARCHIVED EOL TEST RESULTS OF THIS SERIAL NUMBER BEFORE DELIVERY. DURING THE PERFORMANCE TEST, THE GENERATOR IS CONNECTED WITH DIFFERENT DUMMY LOADS AT THE OUTPUT AND IT HAS TO WORK WITH DIFFERENT SUPPLY VOLTAGES. THE NUMBER OF GENERATORS PER BATCH IS ONE. THE EOL TEST FILES ARE WITHIN SPECIFICATION. THE ROOT CAUSE FOR THE PROBLEM IS MOST PROBABLY USER RELATED. THE COMPLAINT RF GENERATOR HAS PAST ALL TESTS (POWER, RESISTANCE, SAFETY) WITHOUT ANY DEVIATION. ACCORDING TO (B)(4) THERE IS NO CAPA NECESSARY
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: TURKEY. IT WAS REPORTED THAT THE DEVICE HAD EXTREME BURNING ISSUES.