BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSTITCH PERFECTPASSER

    MDR report key: 1230325 · Received November 14, 2008

    Report

    Report Number
    2032380-2008-00010
    Event Type
    Other
    Date Received
    November 14, 2008
    Date of Event
    June 20, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    KOG
    PMA / PMN Number
    K062244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SMARTSTITCH PERFECTPASSER SUTURE CARTRIDGE WAS RETURNED TO ARTHROCARE FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND IT WAS CONFIRMED ONE SIDE OF THE CARTRIDGE TIP WAS MISSING, HOWEVER, THE ROOT CAUSE OF THE MISSING TIP CANNOT BE CONFIRMED. THE SUTURE CARTRIDGE IS MANUFACTURED OF MEDICAL GRADE PLASTIC. IF EXHIBITED TO EXCESSIVE FORCES, THE DEVICE CAN BREAK. ARTHROCARE HAS REVIEWED PRODUCT COMPLAINT DATA FOR THIS FAILURE MODE. INCIDENT RATE IS LESS THAN 1%. INSTRUCTIONS FOR USE DOES PROVIDE THAT CAREFUL ATTENTION MUST BE MADE TO ASSURE EXCESSIVE FORCE IS NOT PLACED ON THIS INSTRUMENT. EXCESSIVE FORCE CAN LEAD TO DEVICE FAILURE.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING A SMARTSTITCH PERFECTPASSER WAS REPORTED TO ARTHROCARE CORPORATION. IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, AFTER THE SUTURE CARTRIDGE WAS DEPLOYED AND WHILE REMOVING IT FROM THE PT, IT WAS OBSERVED THAT THE PLASTIC TIP OF THE CARTRIDGE WAS MISSING. IT WAS BELIEVED THAT THE TIP HAD BROKEN OFF INTO THE PT AND WAS NOT RECOVERED. THE SURGERY WAS COMPLETED, INCISION WAS CLOSED, AND THE PT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSTITCH PERFECTPASSER ENDOSCOPIC SUTURE DELIVERY SYSTEM KOG ARTHROCARE CORP. NA 118294

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other