CUTTING ELECTRODE

Additional Manufacturer Narrative

THE CUSTOMER WAS CONTACTED TO OBTAIN ADDITIONAL INFORMATION, BUT NONE COULD BE PROVIDED. THE DEVICE WAS NOT RETURNED AND NO FURTHER EVALUATION COULD BE CONDUCTED; AS A RESULT, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. PREVIOUS COMPLAINTS FROM 2017-2020 WERE REVIEWED; WHILE NO TREND WAS IDENTIFIED FOR THIS REPORTED ISSUE, THREE (3) SIMILAR COMPLAINTS WERE FOUND. PATIENT INJURY WAS NOT REPORTED IN ANY OF THE OTHER OBSERVED CASES. A REVIEW OF PAST REPAIRS FOR PART NUMBER 4624.1313 FOUND THAT NO SAME/SIMILAR REPORTED ISSUES HAD BEEN REPORTED. THE FOLLOWING CAUTIONS, WARNINGS, AND CHECKS ARE OUTLINED IN THE DEVICE INSTRUCTION FOR USE (IFU): 7 USE. WARNING! DO NOT REPROCESS DISPOSABLE ITEMS! THE SERVICE LIFE OF PRODUCTS MARKED "DISPOSABLE", I.E. FOR SINGLE USE ONLY, HAS BEEN DESIGNED FOR ONLY ONE USE IN OR ON A SINGLE PATIENT. IF DISPOSABLE ITEMS ARE REPROCESSED TO BE USED AGAIN, A DETERIORATION OF THE PRODUCT QUALITY CANNOT BE EXCLUDED, ENDANGERING THE PATIENT, USER AND THIRD PARTIES. POSSIBLE DANGERS AND RISK FACTORS ARE STRENGTH PROBLEMS. DAMAGE TO THE PRODUCT. CONSIDERABLE IMPAIRMENT OF THE PRODUCT FUNCTION. GREATELY INCREASED RISK OF INFECTION. BIOCOMPATIBILITY PROBLEMS. IF A DISPOSABLE ITEM IS REPROCESSED, THE PRODUCT RESPONSIBILITY LIES WITH THE USER OR REPROCESSOR. IN THIS CASE THE MANUFACTURER CAN NO LONGER GUARANTEE PRODUCT SAFETY AND PERFORMANCE. CAUTION! THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION AND THEREFORE ENDANGER 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. 8 CHECKS CAUTION! BE CAREFUL IF PRODUCTS ARE DAMAGED OR INCOMPLETE! INJURIES TO THE PATIENT, USER OR OTHERS ARE POSSIBLE. RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. RETURN DAMAGED PRODUCTS TOGETHER WITH ANY LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO CARRY OUT ANY REPAIRS YOURSELF. 8.1 VISUAL CHECK. CHECK THE INSTRUMENTS AND ACCESSORIES FOR THE FOLLOWING: DAMAGE. SHARP EDGES. LOOSE OR MISSING PARTS. ROUGH SURFACES. CHECK THE INSULATION WITH PARTICULAR CARE. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) CONSIDERS THIS CASE CLOSED.

Additional Manufacturer Narrative

USER FACILITY AND MANUFACTURER TO BE CONTACTED TO OBTAIN ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON JANUARY 3RD, 2020, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED VOLUNTARY EVENT REPORT # MW5091826.. THE FOLLOWING WAS REPORTED: LOOP ELECTRODE USED FOR "TURP" PROCEDURE BROKE OFF DURING USE. SURGEON RETRIEVED BROKEN LOOP AND REMOVED IT FROM THE PATIENT.