BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY FORCEPS RADIAL JAW 4 STANDARD CAPACITY W/NEEDLE 2.8MM WORKING CHANNEL

    MDR report key: 7561072 · Received June 1, 2018

    Report

    Report Number
    2134070-2018-00102
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 7, 2018
    Manufacturer
    STERILMED, INC.
    Product Code
    NLU
    PMA / PMN Number
    K042648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A PROCEDURE WITH A BIOPSY FORCEPS RADIAL JAW 4 STANDARD CAPACITY W/NEEDLE 2.8MM WORKING CHANNEL AND THE PATIENT SUFFERED A GASTROINTESTINAL PERFORATION. DURING THE BIOPSY, THE FORCEPS TORE TISSUE IN THE CECUM. TWO ENDO-CLIPS WERE APPLIED TO CLOSE THE TEARS AND REPAIR THE COLON. A NON-RECYCLED BIOPSY FORCEPS WAS USED TO COMPLETE THE BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402870 BIOPSY FORCEPS RADIAL JAW 4 STANDARD CAPACITY W/NEEDLE 2.8MM WORKING CHANNEL FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED NLU STERILMED, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R