BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOCOOL FORCEP HANDLE FLAT INSULATED

    MDR report key: 3033416 · Received April 3, 2013

    Report

    Report Number
    1226348-2013-14836
    Event Type
    Injury
    Date Received
    April 3, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    PK023566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE DEVICE HISTORY RECORDS IT WAS FOUND THAT THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS INCORRECT. THREREFORE IT WAS NOT POSSIBLE TO TO REVIEW THE DEVICE HISTORY RECORDS. IF AT SOMEPOINT THE DEVICE AND/OR LOT NUMBER DOES BECOME AVAILABLE THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. 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

    THE COMPLAINT WAS RE-OPENED AS THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION INDICATED THAT CONDUCTIVITY TESTING WITH A SET OF DISPOSABLE TIPS DEMONSTRATED ADEQUATE CONDUCTIVITY. BASED ON THE SUCCESSFUL TESTING OF THE DEVICE IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT IN THE LABORATORY. IT MIGHT BE POSSIBLE THAT THE CUSTOMER MAY HAVE USED A DAMAGED SET OF TIPS; HOWEVER, THIS COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT DURING THE USE OF THE ISOCOOL BIPOLAR FORCEPS, A MALFUNCTION OF THE DEVICE WITH A POSSIBLE BAD CONTACT BETWEEN THE TIP AND THE FORCEPS WAS DETECTED. THERE WERE NO ADVERSE AFFECTES ON THE PATEINT, HOWEVER THERE WAS A DELAY OF MORE THAN 30 MINUTES.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED - DURING THE USE OF THE ISOCOOL BIPOLAR FORCEPS, WE DETECTED MALFUNCTION OF THE DEVICE, WITH POSSIBLE BAD CONTACT BETWEEN THE TIP AND THE FORCEPS. THE PATIENT DID NOT HAVE ANY DAMAGE. 4/3 ADDITIONAL INFORMATION FROM THE AFFILIATE EXPLAINED THAT THE DISTRIBUTOR SAID THAT THERE WAS A DELAY GREATER THAN 30 MINUTES AS A RESULT OF THE FORCEPS NOT WORKING. NO EVENT DATE PROVIDED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137097 ISOCOOL FORCEP HANDLE FLAT INSULATED DEVICE, ELECTROSURGICAL, CUTTING & COAG & ACCESORIES GEI CODMAN & SHURTLEFF, INC. 1009N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention