BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLASTIC ELECTROSURGICAL DISSECTOR

    MDR report key: 6848871 · Received September 7, 2017

    Report

    Report Number
    1038548-2017-00143
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 27, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    PMA / PMN Number
    K930666
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) 88-5225 ENDOPLASTIC ELECTROSURGICAL DISSECTOR WAS RETURNED FOR EVALUATION AS THE COMPLAINT SAMPLE. THE LOT CODE OF 843371 WAS PRODUCED FEBRUARY OF 2012, WHICH CONFIRMS THAT THE SAMPLE HAS BEEN USED FOR OVER 5 YEARS. THE SAMPLE WAS OBSERVED TO HAVE SIGNIFICANT WEAR TO THE ELECTROSURGICAL COATING, TO THE EXTENT THAT IN TWO LOCATIONS IT WAS POSSIBLE TO SEE THE METAL OF THE SAMPLE. SPECIFICALLY, THE WORKING END OF THE SAMPLE, PAST WHAT IS ACCEPTABLE, AND A SECTION IN THE MIDDLE NEAR THE OVERCOAT LINE SHOWED EXPOSED METAL. SOME DISCOLORATION WAS ALSO OBSERVED ALONG THE BEND TO THE WORKING END. UPON EXAMINATION OF THE B12 ELECTROSURGICAL DEVICE, THE DISCOLORATION APPEARED TO BE DUE TO SOME WEAR UPON THE COATING. THE BREAKS IN COATING APPEARED TO HAVE DIFFERENT ROOT CAUSES BASED UPON OBSERVATIONS. THE BREAK IN THE COATING AT THE FUNCTIONING END IS SPOTTY (NOT ONE LARGE AREA). THIS SPOTTINESS WAS MOST PROBABLY CAUSED BY THE BURNING OF THE COATING. THE CENTER METAL EXPOSED AREA WAS ONE LARGE AREA. THIS AREA WAS MOST PROBABLY CAUSED BY THE WEARING AWAY OF THE COATING OVER TIME. HY-POT (ELECTRICAL INSULATION) TEST WAS PERFORMED ON ALL AREAS ON THIS SAMPLE AND SAMPLE FAILED AT BOTH BREAKS IN THE COATING. IT IS CONFIRMED THAT THERE IS A HIGH POSSIBILITY OF SHOCK AND BURN THROUGH THE TWO EXPOSED METAL SECTIONS. IT WAS MENTIONED THAT THE TECHNICIANS AT THIS HOSPITAL PERFORM TESTS UPON ELECTROSURGICAL INSTRUMENTS AS THIS ONE PRIOR TO USE. IF THESE TESTS INCLUDED AN ELECTRICAL POTENTIAL TEST, IN WHICH THE SAMPLE IS ELECTRICALLY CHARGED AND A CONDUCTIVE MATERIAL WAS RUN UP AND DOWN THE INSULATION TO FIND THE BREAK IN THE COATING, THE TECHNICIAN PROBABLY WOULD HAVE FOUND A DEFECT WITH THIS SAMPLE. FURTHER INFORMATION REGARDING THE SPECIFICS OF THE PROCEDURE PERFORMED, PROXIMITY OF OTHER DEVICES, ELECTRICAL CURRENT USED, PRE-OPERATIVE TESTING, THE CLEANING AND HANDLING INFORMATION WOULD BE NEEDED TO DETERMINE IF THIS WEAR OF THIS INSULATION COULD BE PREVENTED. IF FURTHER INFORMATION IS GIVEN THIS COMPLAINT MAY BE REOPENED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCE'S. THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE. CONCLUSION(S): OTHER ¿ EXPECTED WEAR/ CUSTOMER- DAMAGE THE REPORTED FAILURE COULD BE RECREATED, WITH THE SAMPLE FAILING THE HY-POT TEST. ANY PRESSURE OR CLOSE PROXIMITY TO THE TWO AREAS IN WHICH THE INSULATION DID NOT COVER WOULD MOST LIKELY CAUSE EITHER A SHOCK OR A BURN. THE MOST PROBABLE CAUSE IS A COMBINATION OF THE SAMPLE WAS DAMAGED BY THE CUSTOMER OR REACHED THE POINT THAT THIS COULD BE EXPECTED WEAR BASED ON THE AMOUNT OF USES. WITH THIS PRODUCT ONLY WARRANTED FOR 1 YEAR, THE WEAR EXHIBITED DURING 5X WARRANTY LIFE TO THE INSULATION MADE THIS SAMPLE UNUSABLE. PER (B)(4): DEVICE (INCLUDING INSULATION) MUST BE INSPECTED PRIOR TO USE TO ENSURE INTEGRITY. IF THIS WAS INVOLVED IN THE TESTS PRE-USE PERFORMED THE FAILURE MODE MAY NOT HAVE BEEN PREVENTED, BUT THE INJURY MAY NOT HAVE BEEN INCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT WAS UNDERGOING AN ENDO BREAST AUGMENTATION AND SUSTAINED A BURN FROM THE DISSECTOR (88-5225). THE BURN WAS 1CM X 1 3/4CM, THROUGH THE FAT TO THE MUSCLE AND WAS REPAIRED BY THE SURGEON. THE INJURY OCCURRED ON THE LEFT. THE PATIENT WAS A (B)(6) YO FEMALE WEIGHING (B)(6) KG AND IS (B)(6) CM TALL. THE SURGEON WAS USING THE EMORY ENDO PLASTIC RETRACTOR (88-5200) AND THE CURVED LEFT DISSECTOR (88-5225). (B)(6) 2017 ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER SHE IS IN THE SPD AND DOESN'T KNOW MUCH THAT ISN'T ALREADY REPORTED, THE 88-5225 DEVICE DOES HAVE A BREAK IN THE INSULATION NOTED AFTER THE EVENT AND INSULSCAN FAILED AFTER THE EVENT. THE EVENT REPORTED RETRACTORS WERE IN USE DURING EVENT BUT DID NOT CAUSE THE ISSUE. THE PATIENT REMAINED STABLE. THE DEVICES DO NOT GET THE USAGE TRACKED. THE PATIENT'S BURN ON (B)(6) WAS 1CM X 1 3/4 CM AXILLA THROUGH THE FAT TO THE MUSCLE AND THERE WAS AN UNSPECIFIED REPAIR BY THE SURGEON FOR TREATMENT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629322 ENDOPLASTIC ELECTROSURGICAL DISSECTOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC 88-5225 843371 B12

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention