BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMILAR DEVICE S7001, PMA # P990071

    MDR report key: 4248095 · Received November 13, 2014

    Report

    Report Number
    9612355-2014-00051
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    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

    EVALUATION SUMMARY: (B)(4). IT WAS REPORTED THAT A PATIENT, UNDERWENT A PROCEDURE WITH A STOCKERT GENERATOR AND THE FOOT PEDAL GOT STUCK. THE FOOT PEDAL OF THE GENERATOR WAS NOT ACTIVATED. THEY TRIED RECONNECTING THE REDEL CABLE, REBOOTING THE GENERATOR AND STEPPING ON THE FOOT PEDAL STRONGLY HOWEVER THIS DID NOT IMPROVE THE SITUATION. AFTER A WHILE, THE FOOT SWITCH DID NOT RETURN EVEN IF THE FOOT PEDAL WAS STEPPED ON. IT CONTINUED THE ABLATION. THE PROCEDURE WAS COMPLETED BY USING THE REMOTE SWITCH INSTEAD OF THE FOOT PEDAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. THE DEFECTED PART WAS REPLACED. THE ISSUE WAS RESOLVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE HARDWARE 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A PROCEDURE WITH A STOCKERT GENERATOR AND THE FOOT PEDAL GOT STUCK. THE FOOT PEDAL OF THE GENERATOR WAS NOT ACTIVATED. THEY TRIED RECONNECTING THE REDEL CABLE, REBOOTING THE GENERATOR AND STEPPING ON THE FOOT PEDAL STRONGLY HOWEVER THIS DID NOT IMPROVE THE SITUATION. AFTER AWHILE, THE FOOT SWITCH DID NOT RETURN EVEN IF THE FOOT PEDAL WAS STEPPED ON. IT CONTINUED THE ABLATION. THE PROCEDURE WAS COMPLETED BY USING THE REMOTE SWITCH INSTEAD OF THE FOOT PEDAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE REPORTED ISSUE OF THE FOOT PEDAL GETTING STUCK AND CONTINUED TO ABLATE IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732011 SIMILAR DEVICE S7001, PMA # P990071 LPB STOCKERT GMBH M-5463-320

    Patients

    Seq Age Sex Outcome Treatment
    1