BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.E.E.R. RETRACTOR, ROTO-LOK, RATCHET, 10MM, 32CM

    MDR report key: 751766 · Received August 15, 2006

    Report

    Report Number
    2430952-2006-00032
    Event Type
    Injury
    Date Received
    August 15, 2006
    Report Date
    August 14, 2006
    Manufacturer
    TONTARRA MEDIZINTECHNIX
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THAT WHEN THE SURGEON ENDED THE PROCEDURE, THE SURGEON WAS UNABLE TO UNLOCK THE RETRACTOR. THE PEER WAS REMOVED WITH THE ENDO-CANNULA ATTACHED. FURTHER INFO WAS OBTAINED ON 8/14 STATING THAT: THE TECH REPORTED THAT SURGEON HAD CRANKED THE PEER ALL THE WAY FOR MAXIMUM EXPANSION OF THE INSTRUMENT. WHEN THE SURGEON WENT TO RELEASE THE PEER, THE INSTRUMENT WOULD NOT UNLOCK. THE CAUSE IS UNK. THE SURGEON USED OTHER MALLEABLE RETRACTORS TO GET THE PEER AND TROCAR OUT OF THE PT. THE SURGEON FINISHED THE CASE, AND THE PT WENT INTO RECOVERY DOING FINE. THE PT SUFFERED NO COMPLICATIONS AND IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.E.E.R. RETRACTOR, ROTO-LOK, RATCHET, 10MM, 32CM JARIT ENDOSCOPIC INSTRUMENT KOG TONTARRA MEDIZINTECHNIX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention