BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKLINE

    MDR report key: 4212520 · Received October 24, 2014

    Report

    Report Number
    4212520
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 24, 2014
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH POSTOPERATIVE DIAGNOSIS: RECTAL CANCER.PROCEDURE: LAPAROSCOPIC CONVERTED TO OPEN LOW ANTERIOR RESECTION WITH LAPAROSCOPIC SPLENIC FLEXURE TAKEDOWN AND DIVERTING LOOP ILEOSTOMY.THE PROCEDURE WAS TO INFLATE THE ABDOMEN WITH CARBON DIOXIDE, AND A 10MM TROCAR WAS PLACED. A 5MM TROCAR WAS PLACED IN THE LEFT LOWER QUADRANT. A 15MM TROCAR WAS PLACED IN THE RIGHT FLANK, A 5 MM TROCAR WAS PLACED SUPERIOR TO THAT. THE OMENTUM WAS LIFTED OFF THE TRANSVERSE COLON AND THE LESSER SAC WAS ENTERED. THE SPLENIC FLEXURE WAS THEN TAKEN DOWN AND THE DESCENDING COLON AND SIGMOID COLON WERE FREED WITH THE HARMONIC SCALPEL. THE SURGEON IDENTIFIED THE LEFT COLIC BRANCHES AND DIVIDED THEM WITH THE HARMONIC SCALPEL. THEN, THE SURGEON WAS DISSECTING AROUND THE INTERNAL MAMMARY ARTERY (IMA) PEDICLE WHEN THE BOWEL GRASPER BROKE AND ONE OF THE (DICTATION ANOMALY) FELL OFF. THE SURGEON RETRIEVED THE PIECES OF THE DEVICE AND TOOK A NUMBER OF KIDNEYS, URETERS, AND BLADDER (KUB) AND ABDOMINAL X-RAYS TO BE SURE THAT NOTHING WAS LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680060 CLICKLINE BOWEL GRASPER GCJ KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * A 2.5 MM STAPLER, A MAGNET - A CONTOUR 4.7 MM| COLON WERE FREED WITH THE HARMONIC SCALPEL| A 10 MM TROCAR WAS PLACED DURING THE CASE, A| PURSESTRING| A 5 MM TROCAR WAS PLACED SUPERIOR TO THAT| A 15 MM TROCAR WAS ALSO PLACED IN THE RIGHT FLANK,| 5 MM TROCAR WAS PLACED IN THE LEFT LOWER QUADRANT.| STAPLER, A 31 MM ANVIL THROUGH A 3-0 PROLENE