BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURSE STRING CLAMP

    MDR report key: 6403573 · Received March 14, 2017

    Report

    Report Number
    9610612-2017-00083
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Report Date
    April 27, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    FFN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FINLAND. IT WAS REPORTED THAT THE FORCEPS (PURSE STRING CLAMP) WAS USED FOR SURGERY. THE SUTURE DID NOT HOLD, THE FORCEPS DID NOT FUNCTION PROPERLY. NEW OPERATION WAS NECESSARY DUE TO LESION. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00093.

    Additional Manufacturer Narrative · 1

    CORRECTION MADE TO: PRODUCT CODE. PRODUCT CODE FFN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184168 PURSE STRING CLAMP GENERAL SURGICAL INSTRUMENTS FFN AESCULAP AG EA323R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other