BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 6486233 · Received April 12, 2017

    Report

    Report Number
    1717344-2017-05203
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    April 5, 2017
    Report Date
    June 20, 2017
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE WAS NOT RETURNED; HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER FOR ANALYSIS. THE PRODUCT IN THE PICTURE DID NOT MEET SPECIFICATION. THE PICTURE SHOWED A SECTION OF THE INSULATION ON THE PLUG TO HAVE MELTED. INVESTIGATION OF THE PROVIDED PICTURE FOUND PART OF THE PLUG TO HAVE MELTED. THE INVESTIGATION OF THE PHOTOGRAPH COULD NOT DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S REPORT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH.

    Additional Manufacturer Narrative · 1

    TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON WAS USING A REUSABLE MARYLAND GRASPER (SNOWDEN PENCER INSTRUMENT MODEL NUMBER 90-4002) TO CAUTERIZE THE LIVER AFTER A BIOPSY. THE VALLEYLAB MONOPOLAR CORD WAS USED TO SUPPLY THE CAUTERY. UPON USING COAG AT 80W OF SPRAY, A HOLE WAS CREATED IN THE CONNECTING PART OF THE CABLE WHERE IT ATTACHES TO THE PIN ON THE MARYLAND INSTRUMENT. A SPARK OF FLAME WAS VISUALIZED FROM THIS CONNECTION. THE INSTRUMENTS WERE REMOVED FROM THE PROCEDURE AND REPLACED WITH NEW INSTRUMENTS. THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON WAS USING A REUSABLE MARYLAND GRASPER (SNOWDEN PENCER INSTRUMENT MODEL NUMBER 90-4002) TO CAUTERIZE THE LIVER AFTER A BIOPSY. THE VALLEYLAB MONOPOLAR CORD WAS USED TO SUPPLY THE CAUTERY. UPON USING COAG AT 80W OF SPRAY, A HOLE WAS CREATED IN THE CONNECTING PART OF THE CABLE WHERE IT ATTACHES TO THE PIN ON THE MARYLAND INSTRUMENT. A SPARK OF FLAME WAS VISUALIZED FROM THIS CONNECTION. THE INSTRUMENTS WERE REMOVED FROM THE PROCEDURE AND REPLACED WITH NEW INSTRUMENTS. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267713 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER E0510 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR