COAG ELECTRODE MONO

Description of Event or Problem

USER FACILITY RETURNED THE DEVICE TO RWMIC ON OCTOBER 29, 2018, AND THE EVALUATION WAS COMPLETED ON DECEMBER 04, 2018. THE DEVICE APPEARED TO BE USED - ELECTRODE WAS SEVERELY BENT AND DID NOT FIT FOR USE. THE REPORTED CONDITION WAS VERIFIED USING VISUAL, FUNCTIONAL, AND ELECTRICAL TESTING. THE ELECTRODE WAS FOUND TO BE SOUND, BOTH INSULATION AND CONTINUITY APPEARED TO BE GOOD. THE ROOT CAUSE WAS DETERMINED TO BE AN ISSUE WITH THE CONNECTING CABLE. A MANUFACTURING DEFECT WAS NOT IDENTIFIED.

Additional Manufacturer Narrative

FOLLOW UP REPORT #1 IS TO PROVIDE FDA WITH NEW AND CHANGED INFORMATION. THE FOLLOWING FIELDS HAVE NEW AND CHANGED INFORMATION: A1, A2, A3, A4, B3, B5, D5, E2, E3, F6, F7, F8, F11, F13, G7, H2, H3, H6, H10. DEVICE LABELING WAS REVIEWED FOR PATIENT AND DEVICE CODES, SEE BELOW: -PATIENT CODE: NOT APPLICABLE, NO PATIENT PROBLEM WAS REPORTED. -DEVICE CODE: IFU WAS REVIEWED, SEE BELOW: CAUTION! IRRIGATION FLUID CAN BE ELECTRICALLY CONDUCTIVE! DEPENDING ON THE APPLICATION, A SUITABLE LOW-CONDUCTIVITY IRRIGATION FLUID MUST BE SELECTED BY THE USER. DO NOT USE SALINE (NACL) SOLUTION FOR HF APPLICATIONS. CAUTION! CAREFUL IF HF VOLTAGE IS TOO HIGH! DANGER OF INJURY IF THE INSULATION OF THE HF ELECTRODES IS DAMAGED. EXCEEDING THE MAXIMUM RECURRING PEAK VOLTAGE SPECIFIED FOR THE HF ELECTRODE IN COMBINATION WITH HF SURGICAL DEVICES AND/OR SELECTING THE MODE INCORRECTLY MAY DESTROY THE INSULATION AND CAUSE LEAKAGE CURRENTS THE PATIENT, USER OR OTHERS CAN SUFFER THERMAL TISSUE DAMAGE. ADDITIONAL ATTEMPTS WILL BE MADE TO COLLECT DEVICE INFORMATION FROM THE MANUFACTURER. RWMIC CONSIDERS THIS MATTER OPEN. FOLLOW-UP REPORTS WILL BE SUBMITTED AS REQUIRED.

Additional Manufacturer Narrative

RWMIC CONSIDERS THIS CASE OPEN. RWMIC WILL FOLLOW UP WITH THE USER FACILITY AND MANUFACTURER TO OBTAIN ADDITIONAL AND MISSING INFORMATION.

Description of Event or Problem

ON OCTOBER 17, 2018, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS (RWMIC): WHILE BEING USED DURING A PROCEDURE, THE CORDS AND DEVICE SPARKED. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? UNKNOWN.