BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH & NEPHEW 500 INSUFFLATOR

    MDR report key: 11725555 · Received April 26, 2021

    Report

    Report Number
    1643264-2021-01547
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    January 1, 1901
    Report Date
    June 8, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HIF
    UDI-DI
    03596010673497
    PMA / PMN Number
    K120151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING. THE LEGAL MANUFACTURER FOR THIS PRODUCT, NORTHGATE TECHNOLOGIES INC., WILL REVIEW THE EVENT AND DETERMINE REPORTABILITY. THEY WILL REPORT TO THE FOOD AND DRUG ADMINISTRATION AND ANY OTHER AUTHORITIES AS DEEMED NECESSARY.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN A BI-LATERAL INGUINAL HERNIA REPAIR USING THE SMITH & NEPHEW 500 INSUFFLATOR RESULTED IN A OVER GASSING OF THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625865 SMITH & NEPHEW 500 INSUFFLATOR INSUFFLATOR, LAPAROSCOPIC HIF SMITH & NEPHEW, INC. 72203994 03596010673497

    Patients

    Seq Age Sex Outcome Treatment
    1