PRINCESS

Additional Manufacturer Narrative

DURING THE INVESTIGATION BY THE SPECIALIST DEPARTMENT, IT WAS DETERMINED THAT THE BIPO 21FR 46531313 CUTTING ELECTRODE IS NOT DEFECTIVE. THE SUPPLIED PASSIVE MONO/BIPO WORKING ELEMENT 8653224, BATCH 1578541, SHOWS SIGNS OF CONTAMINATION INSIDE THE LOCKING BODY AS WELL AS TRACES OF AN ARC FROM THE ELECTRODE LOCK TO THE YOKE. THE 20196-119 BIPOLAR CABLE; TUR/TCR; WOLF IS DAMAGED AND TORN IN SEVERAL PLACES. AN EXAMINATION OF THE CUTTING ELECTRODE REVEALS NO SYSTEMATIC DEFECTS FROM A MANUFACTURING OR DESIGN PERSPECTIVE. BASED ON THE RESULTS DESCRIBED ABOVE, THERE IS NO DEFECT. THE CAUSE OF THE ARC IS MOST LIKELY ATTRIBUTABLE TO THE WORKING ELEMENT, AS THIS IS CONTAMINATED INSIDE THE LOCKING BODY AND HAS CAUSED AN ARC FROM THE ELECTRODE LOCK TO THE YOKE. IN GENERAL, THE USER IS ADVISED IN THE USER MANUAL GA-D349, UNDER CHAPTER 8, THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE AND AFTER EACH USE. POTENTIAL DAMAGE OR FUNCTIONAL IMPAIRMENTS CAN BE EASILY IDENTIFIED BY HOSPITAL STAFF IF THESE INSTRUCTIONS ARE FOLLOWED. FURTHERMORE, THE USER IS ADVISED OF THE DEVICE'S STRENGTH LIMITS IN SECTION 7 - 'USE' - AND OF THE DANGER ASSOCIATED WITH ACTIVATING THE ELECTRODE WITHIN AN AIR OR GAS BUBBLE (E.G. BLADDER ROOF), AS WELL AS OF THE INCORRECT SELECTION OF HF OUTPUT POWER IN SECTION 7.2.5 - 'HF APPLICATION' (MONOPOLAR / BIPOLAR). SAFETY INSTRUCTIONS ARE ALSO CLEARLY DESCRIBED IN SECTION 7.2.5.2 - 'HF APPLICATION (BIPOLAR)' REGARDING CAUTION IN THE EVENT OF EXCESSIVE HF VOLTAGE OR POWER, THERMAL DAMAGE AND DISTAL WEAR OF THE ELECTRODE DUE TO CONTINUOUS ACTIVATION OF THE BIVAP ELECTRODE, AS WELL AS INCREASED ELECTRODE WEAR CAUSED BY AN EXCESSIVELY HIGH POWER SETTING. IN THE RISK ASSESSMENT P08F0015 (RISK ASSESSMENT 882-3 NON-REUSABLE RESECTION ELECTRODES REV 05), THE POTENTIAL RISKS ARISING FROM FAILURE WERE ASSESSED IN TERMS OF THE EXTENT OF DAMAGE, THE ASSUMED PROBABILITY OF OCCURRENCE AND THE PROBABILITY OF FAILURE AND WERE DEEMED ACCEPTABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A HYSTEROSCOPY PROCEDURE, AN UNUSUAL EFFECT OCCURRED AT THE PROXIMAL END OF THE ELECTRODE (THE PART CONNECTED TO THE WORKING ELEMENT), DUE TO A SUDDEN AND UNCONTROLLED ELECTRICAL EVENT. THIS INCIDENT WAS NOT PRECEDED BY ANY NOTICEABLE IRREGULARITIES IN THE FUNCTIONING OF THE EQUIPMENT. THE PROCEDURE WAS IMMEDIATELY STOPPED WHEN THE EVENT OCCURRED. THERE ARE NO REPORTS OF INJURIES TO THE PATIENT. HOWEVER, THE OPERATOR REPORTED A SLIGHT SCORCHING ON THEIR GLOVES.