BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CP393-2 4.5M BIPOLAR VALLEYLAB

    MDR report key: 6828103 · Received August 29, 2017

    Report

    Report Number
    2523190-2017-00088
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Report Date
    August 4, 2017
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON SEPTEMBER 13, 2017. RESULTS: DEVICE 1-CABLE CP393-2 4.5M BIPOLAR . EVALUATION OF RETURNED DEVICE; NO EXTERNAL DAMAGE: NO TRACES OF CUT OR IMPACTS ON THE CABLE HAVE BEEN NOTED. A CONDUCTIVITY TEST HAS BEEN CARRIED AND NO ISSUES WERE FOUND BUT SOME ELECTRICAL LEAKS COULD EXIST. LOT AND MANUFACTURING DATE UNKNOWN. DHR REVIEW; UNABLE TO REVIEW THE APPLICABLE DHR AS THE LOT NO. WAS UNAVAILABLE. COMPLAINTS HISTORY; NO ADVERSE TREND - FIRST OCCURRENCE OF THIS RISK FOR THIS DEVICE. CONCLUSION: A COMPLAINT INVESTIGATION (FAILURE ANALYSIS) AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE AS THE COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT SAMPLE MET SPECIFICATION REQUIREMENTS. 6 OTHER PRODUCTS WERE RETURNED FOR EVALUATION. RESULTS: DEVICE 2 OF 7 -TUBE CEV6795B DIA 5MM 350MM . DHR FOR LOT NO. 1699842 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. COMPLAINTS HISTORY - NO ADVERSE TREND - NO ISSUE ON THE TUBE CEV6795B. CONCLUSION - A COMPLAINT INVESTIGATION (FAILURE ANALYSIS) AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE AS THE COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT SAMPLE MET SPECIFICATION REQUIREMENTS. MANUFACTURED ON 17OCT2016. DEVICE 3 OF 7 - TUBE CEV6795B DIA 5MM 350MM. DHR FOR LOT NO. 1699842 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. COMPLAINTS HISTORY - NO ADVERSE TREND - NO ISSUE AND NO ELECTRICAL RISK FOR TUBE CEV6795B . CONCLUSION - A COMPLAINT INVESTIGATION (FAILURE ANALYSIS) AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE AS THE COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT SAMPLE MET SPECIFICATION REQUIREMENTS. MANUFACTURED ON 17OCT2016. DEVICE 4 OF 7 - BIPOLAR HANDLE CEV669BG DIA 5MM ERG . DHR FOR LOT NO. 2012496 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED . COMPLAINTS HISTORY - INCLUDING THIS COMPLAINT, THE COMPLAINT RATE FOR PRODUCT FAMILY BIPOLAR HANDLE FOR THE PAST 12 MONTHS IS (B)(4) COMPLAINTS /PRODUCT USES. THIS IS NOT A STATISTICALLY ADVERSE TREND USING CHI² TEST WHEN COMPARED TO THE COMPLAINT RATE OF (B)(4) COMPLAINTS / PRODUCT USES FOR THE PRIOR 13-24 MONTHS. CONCLUSION -THE HANDLE FAILED ELECTRICAL TEST. THE BLACK PLASTIC PART IS BURNT ON ITS INNER PART. MANUFACTURED ON 29MAR2017. THE REPORTED BURNS ON THE PLASTIC PART ARE LIKELY THE CONSEQUENCE OF THE FORMATION OF A SHORT CIRCUIT WITH AN ELECTRIC ARC INSIDE THE DEVICE DUE TO THE PRESENCE OF HUMIDITY / RESIDUES IN THE CONNECTION ZONE. THESE ELECTRIC ARCS COULD ENTAIL SPARKS, SMOKE OR CRACKING. THE ORIGIN OF THE HUMIDITY RESPONSIBLE FOR THESE REPORTED COMPLAINTS COULD BE: SOME RESIDUAL HUMIDITY THAT WAS PRESENT BEFORE USE FROM A LACK OF DRYING OF THE DEVICE OR OF THE CABLE DURING REPROCESSING OR A DEFECT OF CLEANING OF THE INSTRUMENT (BLOOD OR TISSUES). SOME INFILTRATION OF BODY FLUIDS FROM THE PATIENT ALONG THE TUBE DURING SURGERY . SOME CONTAMINATION BY FLUIDS DURING SURGERY I.E. LIQUID SPILLED ON THE HANDLE DURING SURGERY , OR INSTRUMENT IN CONTACT WITH LIQUIDS WHEN NOT USED. DEVICE 5 OF 7 - MCEN54P - HANDLE MCEN54P DIA 5MM ANG BIPOLAR DESSI. DHR FOR LOT NO. 1769392 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. COMPLAINTS HISTORY - INCLUDING THIS COMPLAINT, THE COMPLAINT RATE FOR PRODUCT FAMILY BIPOLAR HANDLE FOR THE PAST 12 MONTHS IS (B)(4) COMPLAINTS /PRODUCT USES. THIS IS NOT A STATISTICALLY ADVERSE TREND USING CHI² TEST WHEN COMPARED TO THE COMPLAINT RATE OF (B)(4) COMPLAINTS / PRODUCT USES FOR THE PRIOR 13-24 MONTHS. CONCLUSION - THE HANDLE FAILED ELECTRICAL TEST. THE BLACK PLASTIC PART IS BURNT AT THE CONNECTION. MANUFACTURED ON 25NOV2016. THE REPORTED BURNS ON THE PLASTIC PART ARE LIKELY THE CONSEQUENCE OF THE FORMATION OF A SHORT CIRCUIT WITH AN ELECTRIC ARC INSIDE THE DEVICE DUE TO THE PRESENCE OF HUMIDITY / RESIDUES IN THE CONNECTION ZONE. THESE ELECTRIC ARCS COULD ENTAIL SPARKS, SMOKE OR CRACKING. THE ORIGIN OF THE HUMIDITY RESPONSIBLE FOR THESE REPORTED COMPLAINTS COULD BE: SOME RESIDUAL HUMIDITY THAT WAS PRESENT BEFORE USE FROM A LACK OF DRYING OF THE DEVICE OR OF THE CABLE DURING REPROCESSING OR A DEFECT OF CLEANING OF THE INSTRUMENT (BLOOD OR TISSUES). SOME INFILTRATION OF BODY FLUIDS FROM THE PATIENT ALONG THE TUBE DURING SURGERY SOME CONTAMINATION BY FLUIDS DURING SURGERY I.E. LIQUID SPILLED ON THE HANDLE DURING SURGERY , OR INSTRUMENT IN CONTACT WITH LIQUIDS WHEN NOT USED. DEVICE 6 OF 7 - CEV634-1A - BIPOLAR INSERT CEV634-1A 350MM MOUIEL. DHR FOR LOT NO. 143760 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED COMPLAINTS HISTORY - INCLUDING THIS COMPLAINT, THE COMPLAINT RATE FOR PRODUCT FAMILY BIPOLAR ELECTRODE FOR THE PAST 12 MONTHS IS (B)(4) COMPLAINTS /PRODUCT USES. THIS IS NOT A STATISTICALLY ADVERSE TREND USING CHI² TEST WHEN COMPARED TO THE COMPLAINT RATE OF (B)(4) COMPLAINTS / PRODUCT USES FOR THE PRIOR 13-24 MONTHS. CONCLUSION - THE TWO WIRES AND DISTAL RING SLIGHTLY CAME OUT OF THE TUBE. HOWEVER, THE RISK FOR THE PATIENT OR THE USER IS VERY LOW SINCE THE INSERT CANNOT BE USED IN THIS CONDITION. MANUFACTURED ON 24DEC2015. THE CAUSE OF THIS DEFECT CANNOT BE DETERMINED WITH ABSOLUTE CERTAINTY. IT MAY COME FROM A GLUING DEFECT OF THE ELECTRODES INSIDE THE TUBE OR AN EXCESSIVE EFFORT DURING AN ATTEMPT TO ASSEMBLE THE INSERT ON A HANDLE. DEVICE 7 OF 7 - CEV636-1A - BIPOLAR INSERT CEV636-1A 350MM GAYET. DHR FOR LOT NO. 2219140 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. COMPLAINTS HISTORY - NO ADVERSE TREND - NO HIGHLIGHTED ISSUE. CONCLUSION - A COMPLAINT INVESTIGATION (FAILURE ANALYSIS) AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE AS THE COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT SAMPLE MET SPECIFICATION REQUIREMENTS. MANUFACTURED ON 13JUL2017.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE HAD SPARKS AND STARTED BURNING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606635 CABLE CP393-2 4.5M BIPOLAR VALLEYLAB PFM16 GEI INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1