BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAR DEVICE S7001, PMA # P990071

    MDR report key: 5494169 · Received March 10, 2016

    Report

    Report Number
    9612355-2016-00015
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 2, 2016
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE FOR (B)(4) IS NOVEMBER 2012. THIS STOCKERT WAS MANUFACTURED BEFORE SEPTEMBER 24, 2014, THEREFORE NO UDI IS APPLICABLE FOR THIS PRODUCT WITH SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD - ACTUAL DEVICE EVALUATED - (B)(4). RESULTS - FRICTION PROBLEM -(B)(4) - A DEVICE PROBLEM CAUSED BY ITS SURFACE COMING IN CONTACT WITH ANOTHER SURFACE OR FLUID. CONCLUSION - DEVICE DIFFICULT TO OPERATE - (B)(4). DEVICE PROBLEMS INCLUDING SET-UP, OPERATION, AND DISASSEMBLY OF EQUIPMENT. (B)(4). IT WAS REPORTED THAT THE FOOT PEDAL DID NOT GET BACK IN PLACE IMMEDIATELY WHEN THE FOOT PEDAL WAS STOPPED TO BE STOMPED DURING THE ABLATION FOR PVI. THE PEDAL WAS GOT BACK AFTER A WHILE. AT THAT TIME THE ABLATION WAS STOPPED. THE PROCEDURE WAS COMPLETED WITHOUT USING THE FOOT PEDAL. THE ABLATION WAS CONDUCTED BY THE REMOTE OF THE J70. THE DEVICE WAS EVALUATED AND FOOT PEDAL MECHANICAL WAS DEFECTIVE.  FOOT PEDAL WAS REPLACED. ISSUE WAS RESOLVED. THE DEVICE WAS ALSO SUBJECTED TO PM, SAFETY AND FUNCTIONAL TESTING AND ALL TESTS PASSED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CONTACT OFFICE AND MANUFACTURING SITE SHOULD REFLECT: (B)(4). MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOOT PEDAL DID NOT GET BACK IN PLACE IMMEDIATELY WHEN THE FOOT PEDAL WAS STOPPED DURING THE ABLATION FOR PULMONARY VEIN ISOLATION PROCEDURE. THE FOOT PEDAL GOT STUCK AND CONTINUED ABLATION, AND STOP BUTTON WAS USED TO STOP ABLATION. WHEN PRESSED FOOT PEDAL AGAIN, ABLATION STARTED AS USUAL. THE PROCEDURE WAS COMPLETED WITHOUT USING FOOT PEDAL. THE ABLATION WAS CONDUCTED BY THE REMOTE OF THE STOKERT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THIS IS MDR REPORTABLE AS IT POSED POTENTIAL RISK FOR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150002 SIMILAR DEVICE S7001, PMA # P990071 LPB STOCKERT GMBH M-5463-320

    Patients

    Seq Age Sex Outcome Treatment
    1