BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2971381 · Received September 13, 2006

    Report

    Report Number
    9610617-2006-00053
    Event Type
    Other
    Date Received
    September 13, 2006
    Date of Event
    July 31, 2006
    Report Date
    September 11, 2006
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER, THIS PRODUCT WAS MAINTENANCE AND REPROCESSED BY ON-SITE TECH FROM SURGICAL SERVICES INC./ TELEFAX MEDICAL. PER SSI, THEY RE-SHEATHED AND POSSIBLY SPOT WELDED THIS SUBJECT INSTRUMENT BEFORE. NO PRODUCT WAS RETURNED TO US FOR EVAL. ALTHOUGH IT STILL BEARS THE KARL STORZ NAME, IT IS NO LONGER A GENUINE KARL STORZ PRODUCT.

    Description of Event or Problem · 1

    DURING A THORACIC PROCEDURE, THE DISSECTING CANNULA HOOK WAS USED AND THE TIP BROKE OFF. THE BROKEN PIECE WAS NOT RETRIEVED. THE DOCTOR REPLACED THE INSTRUMENT AND COMPLETED THE PROCEDURE. THE DOCTOR STATED THAT HE DID NOT THINK THE BROKEN PIECE PRESENTED ANY DANGER TO THE PT AT THIS TIME AND HE PLANS TO RETRIEVE THE BROKEN TIP WHEN HE REMOVES THE PECTUS BARS (TO CORRECT CONCAVITY) HE PLACED INSIDE THE PT'S CHEST IN 2 YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CANNULA KNS KARL STORZ GMBH & CO. KG 37370DU CI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other