BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    33 CM PKS PLASMASPATULA W/CORD (5/PK)

    MDR report key: 9510707 · Received December 23, 2019

    Report

    Report Number
    2951238-2019-01231
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    November 26, 2019
    Report Date
    January 20, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K041633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE 952005PK PKS PLASMASPATULA WITH LOT NUMBER FR867130 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OBSERVED THAT THE PLASTIC COUPLING (PN: 140272, 140273) WAS MELTED AT THE DISTAL TIP. IN ADDITION, THE DISTAL TIP WAS COVERED IN COAGULATED MATERIAL SHOWING SIGNS OF HEAVY USE. OTHER DISTAL-END COMPONENTS ARE INTACT AND PRESENT. THE RETRIEVED FRAGMENTS WERE NOT RETURNED FOR EVALUATION. THE BLACK HEAT SHRINK WAS REMOVED FROM THE DISTAL END TO CONFIRM THE WHITE PLASTIC COUPLING WAS IN PLACE AND INTACT PROXIMAL TO THE DAMAGE OBSERVED AT THE DISTAL TIP. THERE WERE NO ADDITIONAL ABNORMALITIES WERE OBSERVED DURING THE EVALUATION. ADDITIONALLY, THE SHAFT, HANDLE, CORD AND PLUG ARE INTACT AND FREE FROM DAMAGE. THE DHR FOR THE SUBJECT DEVICE WAS REVIEWED AND THE REVIEW FOUND THAT ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. A TOTAL OF 100 UNITS WERE PRODUCED UNDER THIS LOT NUMBER WITH NO ASSOCIATED NCRS, REPORTED SCRAP OR RECORDED PROCESS DEVIATIONS RELATING TO THE REPORTED FAILURE. BASED ON DEVICE RETURN INVESTIGATION RESULTS, THE REPORTED FAILURE IS LIKELY DUE TO A RESULT OF PROLONGED ACTIVATION. AS A PRECAUTIONARY MEASURE AND AS STATED ON THE USER MANUAL, PER THE DEVICE IFU (P9100497-001 REV BC), "AVOID UNNECESSARY AND PROLONG ACTIVATION. THIS MAY RESULT IN EXCESSIVE HEATING, WHICH COULD DAMAGE THE INSTRUMENT TIP OR COULD DAMAGE SENSITIVE TISSUE STRUCTURES.

    Description of Event or Problem · 0

    ISSUE OCCURRED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), BILATERAL SALPINGECTOMY, CYSTOSCOPY, LAPAROSCOPIC COLPOPEXY.THE WHITE PIECE BROKE OFF WHILE CAUTERIZING AND CUTTING THE VAGINAL CUFF.PROCEDURE WAS DELAYED APPROXIMATELY 8 TO 10 MINUTES TO RETRIEVE THE BROKEN PIECES. THE WHITE PIECES WERE RECOVERED FROM THE ABDOMINAL CAVITY LAPAROSCOPICALLY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION, THEREFORE THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHITE PART OF THE TIP FELL OFF DURING A PROCEDURE. THE DETACHED PART WAS RETRIEVED FROM THE PATIENT AND NO HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307190 33 CM PKS PLASMASPATULA W/CORD (5/PK) 33 CM PKS PLASMASPATULA W/CORD (5/PK) GEI GYRUS ACMI, INC 952005PK FR867130

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR