SHARK/S-LINE

Additional Manufacturer Narrative

A TOTAL OF 3 ELECTRODES 4622.1333 SCHNEIDE-ELEKTRODE BIPO 22CH 12/30° ARE AVAILABLE. TWO OF THE ELECTRODES SHOW A FRACTURE AT THE DISTAL WIRE BOW. ONE ELECTRODE SHOWS A BILATERAL FRACTURE OF THE DISTAL WIREFRAME. THE WIREFRAME IS NO LONGER PRESENT. THE WIREFRAME SHOWS LITTLE TO NO THERMAL DAMAGE OVER LARGE PARTS. HOWEVER, CLEAR DISCOLORATIONS AND METAL DEFORMATIONS CAN BE SEEN ON THE FRACTURE SURFACES, WHICH INDICATE THERMAL DAMAGE. PHOTOS OF THE ELECTRODES WERE DOCUMENTED. THE CHANGES VISIBLE ON THE ELECTRODES INDICATE A MECHANICAL OVERLOAD, POSSIBLY WITH ADDITIONAL INFLUENCE FROM THE USE OF HF CURRENT. EXCESSIVE FORCE EXERTED BY THE USER MAY RESULT IN MECHANICAL FAILURE OF THE WIREFRAME. THE USER IS THEREFORE ADVISED IN THE INSTRUCTIONS FOR USE TO KEEP THE APPLICATION OF FORCE LOW. CORRESPONDING RISKS ARE LISTED AND ASSESSED IN THE RISK ASSESSMENT BB2-3. WHEN USED WITH HF CURRENT, THE SYSTEM CAUSES AGEING OF THE APPLICATION PART (IN THIS CASE THE WIREFRAME). THIS WEAR DEPENDS ON MANY FACTORS SUCH AS THE TYPE OF HF GENERATOR, SETTING OF THE HF GENERATOR, TISSUE CONTACT, CUTTING SPEED, ETC. THE WEAR AND TEAR OF THE WIREFRAME IS CAUSED BY THE TYPE OF HF GENERATOR USED. IF THE POWER SETTINGS OF THE HF GENERATOR ARE TOO HIGH, RAPID WEAR CAN OCCUR WITHIN ONE APPLICATION, WHICH EVENTUALLY LEADS TO THE FRACTURE OF THE APPLICATION PART. THE USER IS THEREFORE ADVISED IN THE OPERATING INSTRUCTIONS TO KEEP THE POWER SETTING LOW. CORRESPONDING RISKS ARE LISTED AND EVALUATED IN THE BB2-3 RISK ASSESSMENT. THE EXACT PARAMETERS OF THE HF GENERATOR HAVE NOT BEEN MADE AVAILABLE, SO EFFECT OF THE GENERATOR SETTINGS CANNOT BE FULLY ASSESSED. THE CORRECT SELECTION OF THE POWER AND MODE OF THE RF GENERATOR IS AN ESSENTIAL POINT IN THE APPLICATION OF BIPOLAR RESECTION. THE INSTRUCTIONS FOR USE GA-D342 APPLICABLE TO THIS SYSTEM REFERS TO THIS POINT WITH DIFFERENT WARNINGS: FROM THE INSTRUCTIONS FOR USE, GA-D342: CAUTION! CAREFUL IF THE HF VOLTAGE / POWER IS SET TOO HIGH! DANGER OF INJURY RESULTING FROM DAMAGE TO THE ELECTRODE INSULATION! DAMAGED INSULATION CAN CAUSE LEAKAGE CURRENTS. THERMAL DAMAGE TO THE PATIENT AND / OR USER ARE POSSIBLE. REPLACE ELECTRODE. NOTE! EXCESSIVE POWER SETTINGS CAN CAUSE CLEARLY INCREASED ELECTRODE WEAR. WE RECOMMEND STARTING AT A LOWER POWER SETTING TO DETERMINE THE OPTIMUM POWER SETTING. CAUTION! THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIRS THE FUNCTION AND THEREFORE ENDANGERS THE PATIENT. IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS. MAKE SURE THAT NO MISSING PARTS REMAIN IN THE PATIENT. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. NO PRODUCT OR MANUFACTURING PROBLEM EVIDENT. A HANDLING ISSUE IS INDICATED. A REVIEW OF THE COMPLAINTS DATABASE SHOWS NO ADVERSE TREND. POSSIBLE HAZARDS WERE CONSIDERED IN THE RISK ASSESSMENT BB-2-3 R05 WITH THE CORRESPONDING EXTENT OF DAMAGE AND PROBABILITY OF OCCURRENCE AND ASSESSED WITH AN ACCEPTABLE RISK. THIS ASSESSMENT IS STILL VALID EVEN TAKING INTO ACCOUNT THE CURRENT CASE. AS THERE IS NO SYSTEMIC ISSUE RELATED TO THE PRODUCT OR ITS MANUFACTURE, NO FURTHER INVESTIGATION OR ACTION IS WARRANTED FOR THIS CASE. (B)(4).

Description of Event or Problem

THE CUSTOMER COMPLAINED ABOUT BIPOLAR CUTTING ELECTRODES 4622.1333. ACCORDING TO THE CUSTOMER, 3 ELECTRODES ARE "BURNT OUT" WHEN USED ON THE PATIENT. INFORMATION ON GENERATOR SETTINGS, DURATION AND TYPE OF APPLICATION OR PRODUCTS USED IN COMBINATION ARE NOT AVAILABLE. NO ADVERSE CONSEQUENCES FOR THE PATIENT. RICHARD WOLF COMPLAINT REFERENCE NUMBER (B)(4).