BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENA MUSCLE STIMULATOR PROBE

    MDR report key: 2515170 · Received March 29, 2012

    Report

    Report Number
    9612007-2012-00010
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF SIX REPORTS (SAME USER FACILITY, SAME PRODUCT ID, DIFFERENT PTS). IT WAS REPORTED THAT THE USER FACILITY HAS 6 PENA STIMULATOR PROBES THAT THE PHYSICIAN HAS BEEN UNABLE TO USE. THE COPPER CABLING INSIDE THE INSULATED SHEATH WAS BLACK AND OXIDIZED. IT WAS BELIEVED BY THE USER FACILITY THAT THIS WAS THE REASON THE PENA STIMULATOR PROBES DID NOT WORK PROPERLY. THE CABLE FAILED TO MAKE ELECTRICAL CONTACT WITH THE PRONGS AS THE COPPER WIRE STRANDS WERE OXIDIZED AND DAMAGED. THIS STARTED AT THE SOLDERED JUNCTION WITH THE BANANA PLUG SHAFT AND WORKED ITS WAY PROXIMALLY TOWARDS THE PROBE. IT WAS STATED THAT IT MUST BE RELATED TO THE OXIDATION/CHEMICAL ATTACK DURING THE STERILIZATION PROCESS, WITH THE AGENT SEEPING THROUGH THE PLUG AND BETWEEN THE COPPER STRANDS AND THE CABLE INSULATION SLEEVE. THERE WERE 2 PROBES FROM (B)(6) 2012 (EXACT DATE COULD NOT BE PROVIDED) AND 4 PROBES FROM THE (B)(6) 2012 THAT HAD THIS PROBLEM. IT WAS REPORTED THAT THE PHYSICIAN CUT INTO ONE OF THE PROBES AND STATED THAT THE COPPER CABLING WAS BLACK AGAIN. THE PROBES ALL CAME INTO CONTACT WITH PTS. THE PTS WERE ALREADY ANAESTHETIZED WHEN THE PROBE WAS TRIED ON THEM. IT WAS REPORTED THAT ALL OF THE PTS WERE UNDER THE AGE OF 2 AND THEY WERE USED FOR ANAL RECTAL MALFORMATION. THERE HAVE BEEN NO RESULTANT INJURIES TO ANY OF THE PTS. NO OTHER PT INFO PROVIDED. THE EVENT DID LEAD TO AN INCONVENIENCE AND AN INCREASE OF SURGERY TIME OF ABOUT 20 MINUTES OR SO UNTIL NEW PROBES WERE LOCATED, TRIED, AND FOUND TO HAVE WORKED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENA MUSCLE STIMULATOR PROBE PENA STIMULATOR PROBE IPF INTEGRA NEUROSCIENCES IMPLANTS S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other