BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE II REM RET EL W/CORD

    MDR report key: 7371955 · Received March 26, 2018

    Report

    Report Number
    1717344-2018-00397
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 5, 2018
    Report Date
    May 2, 2018
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    20884524000074
    PMA / PMN Number
    K822572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THIS DEVICE HAD NOT BEEN USED IN THE TREATMENT OR DIAGNOSIS OF THE PATIENT. VISUAL INSPECTION FOUND THAT THE TERMINAL CONNECTION WAS UNSEALED WITH THE EXPOSED METAL ELEMENTS. THE CUSTOMER REPORTED THAT THE DEVICE COMPONENT WAS LOOSER; LINTING. THE REPORTED CONDITION WAS NOT CONFIRMED, A COMPONENT WAS MISSING. THE INVESTIGATION OBSERVED THERE WAS NO TERMINAL COVER AND THE METAL CONDUCTORS ON THE TERMINAL SIDE OF THE CORD WAS EXPOSED. THE DEVICE WAS NOT USED ON A PATIENT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ONE DEVICE WAS RECEIVED FOR EVALUATION. THIS DEVICE HAD NOT BEEN USED IN THE TREATMENT OR DIAGNOSIS OF THE PATIENT. A REVIEW OF THE LOT NUMBER REPORTED INDICATES THAT THE PRODUCT WAS WITHIN THE ASSIGNED EXPIRATION DATE AT THE TIME OF THE REPORTED INCIDENT. THE RETURNED PRODUCT DID NOT MEET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND THAT THE TERMINAL CONNECTION WAS UNSEALED WITH THE EXPOSED METAL ELEMENTS. THE REPORTED CONDITION WAS CONFIRMED. THE TERMINAL COVER WAS MISSING FROM THE PAD. THE INVESTIGATION OBSERVED THERE WAS NO TERMINAL COVER AND THE METAL CONDUCTORS ON THE TERMINAL SIDE OF THE CORD WAS EXPOSED. THE DEVICE WAS NOT USED ON A PATIENT. THE PRODUCT ENGINEER CONCLUDED THAT THE PAD MIGHT HAVE INADVERTENTLY PLACED IN A BIN FOR PACKAGE PROCESS OR ON THE CONVEYOR FOR PACKAGING PROCESS WHERE THE OPERATOR AT THE FOR MOST FAILED TO DETECT THE BAD PAD DURING LOADING INSPECTION; THIS HUMAN MISS LED TO A BAD PAD TO BE AT CUSTOMER SITE. IF THE INSPECTION PROCESS AT LOADING WAS CONDUCTED PER TMI 1048848, SECTION 25, THEN THIS DEFECTIVE PAD WOULD HAVE BEEN REJECTED AND NOT PACKAGED ON FORMOST 2. DUE TO HUMAN ERROR INVOLVED IN THIS COMPLAINT A QUALITY ALERT WAS ISSUED TO THE MANUFACTURING FLOOR AND RETRAINING WAS DONE WITH THE PACKAGING OPERATORS FOR ALL SHIFTS. THIS IS THE FIRST OCCURRENCE OF THIS TYPE OF NON-CONFORMANCE FOR THE PAST TWO YEARS. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE MANUFACTURING ERROR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE PACKAGING WAS OPENED AND THE PRODUCT WAS REMOVED, IT WAS NOTED THAT THE CONNECTION BETWEEN THE PAD AND THE ELECTRIC CABLE WAS FAULTY. THE CONNECTION WAS UNSEALED WITH THE EXPOSED METAL ELEMENTS AND EXPOSED BOTH ON THE PATIENT'S SIDE AND ON THE EXTERIOR SIDE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212115 POLYHESIVE II REM RET EL W/CORD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER E7507 72020055X 20884524000074

    Patients

    Seq Age Sex Outcome Treatment
    1