BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMC-V FOOTPEDAL

    MDR report key: 4857101 · Received June 19, 2015

    Report

    Report Number
    1226348-2015-10360
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    May 27, 2015
    Manufacturer
    SYNERGETICS INC.
    Product Code
    GEI
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE EVALUATION OF THE FOOT PEDAL CONFIRMED THE COMPLAINT. BOTH PEDALS WERE LABELED CUT NOT CUT AND COAG. THIS FOOT PEDAL IS OBSOLETE. NO CONTAINMENT IS NEED. ROOT CAUSE FOR THE ESCAPE EVENT - THE DECAL PART NUMBER INCLUDED 3 DIFFERENT PART LABELS. THE INSPECTION FORM DOES NOT REQUIRE VERIFYING ALL THREE DECALS (CUT, COAG AND PART #). CORRECTIVE ACT- NONE NEEDED. THIS PART NUMBER IS OBSOLETE. THE ROHS VERSION REQUIRES INSPECTION OF THE THREE DECALS PER DRAWING. SUPPLIER EVALUATION REVEALED: PRODUCT HAD CUT ON BOTH SIDES OF FOOTPEDAL. COAG NEEDS TO BE LABELLED WITH COAG OVERLAY. A DHR REVIEW WAS PERFORMED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. FIX: APPLIED COAG LABEL TO COAG PEDAL. RETESTED FOOT SWITCH. UNIT PASSED ON FINAL ACCEPTANCE TEST. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE COAG FOOTPEDAL HAD THE WRONG LABEL INDICATING ¿CUT¿, NOT ¿COAG¿. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399823 CMC-V FOOTPEDAL ELECTROSURGICAL GENERATOR GEI SYNERGETICS INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention