BEUDAMED
    FDA Adverse Event Summary report: N

    12X100MM KII Z-THREAD ACC SYS W/SHLD BID OBTURATOR

    MDR report key: 2842446 · Received November 14, 2012

    Report

    Report Number
    2027111-2012-00350
    Date Received
    November 14, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 14, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    LZN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROSCOPIC PLACEMENT AND LAPAROTOMY INCISION TO CONTROL RETROPERITONEAL BLEEDING - "WHEN PLACING TROCAR IT IS BELIEVED THAT THE BLADE DID NOT RETRACT AFTER ENTERING THE PERITONEUM." "AN INCISION WAS MADE IN THE LEFT LATERAL ABDOMEN AND THE LEFT LATERAL SLEEVE PLACED; AND ONCE THIS SLEEVE WAS PLACED AND WE HAD PULLED OUT THE TROCAR, WE LOOKED WHERE IT HAD GONE AND WE COULD SEE BLEEDING STARTING TO WELL UP FROM UNDER THE BOWEL. LOOKING THROUGH THIS SLEEVE WITH AN IRRIGATOR-ASPIRATOR AND TRYING TO IDENTIFY THE FOCUS OF THE BLEEDING WITH THE GRASPER COMING THROUGH THE SUPRAPUBIC SLEEVE, IT WAS JUST TOO DIFFICULT AND THE BLEEDING APPEARED TO BE FAST ENOUGH THAT IF WE COULD NOT GET IT CONTROLLED AND CLIPPED WITHIN A FEW MINUTES, WE WOULD HAVE TO PROCEED WITH LAPAROTOMY. THOUGH IT WAS BEING VIEWED UNDER MAGNIFICATION AND APPEARED LIKE THERE WAS VERY SIGNIFICANT BLEEDING AND WE COULD SEE FLOW AND SO AFTER AN ATTEMPT TO ISOLATE THE BLEEDER LAPAROSCOPICALLY WHICH WAS UNSUCCESSFUL, THE DECISION WAS MADE TO PROCEED WITH AN EXPLORATORY LAPAROTOMY TO CONTROL THIS BLEEDER. A VERTICAL INCISION WAS MADE FROM THE PUBIC SYMPHYSIS UP TO UNDER THE UMBILICUS AND AROUND THE LEFT SIDE OF THE UMBILICUS AND ABOUT THREE FINGERBREADTHS ABOVE, AND THIS WAS CARRIED DOWN TO THE ANTERIOR RECTUS FASCIA, WHICH WAS INCISED VERTICALLY AND THEN THE INCISION CARRIED DOWN TO THE PERITONEUM, WHICH WAS INCISED VERTICALLY. IMMEDIATELY IRRIGATION WAS PUT IN THERE TO TRY TO DECREASE THE CLOT AND IDENTIFY THE BLEEDER AND THE BOWEL WAS PULLED OUT; AND AS WE WERE PULLING OUT, WE WERE INSPECTING THE SMALL BOWEL AND LARGE BOWEL ALSO. WE WERE ABLE TO GET DOWN TO WHERE WE DID FIND ABOUT A 1.5-CM INCISION AT THE ROOT OF THE MESENTERY MEDIAL TO WHERE WE COULD PALPATE THE AORTA TO BE. THERE WAS SOME BRUISING OF THE RETROPERITONEUM BUT A SINGLE FIGURE-OF-EIGHT STITCH OF A 2-0 CHROMIC WAS PLACED RELATIVELY SUPERFICIALLY BECAUSE OF DEEPER STRUCTURES; AND ONCE THIS WAS LIGATED DOWN, THE ACTIVE BLEEDING APPEARED TO HAVE STOPPED. SOME PRESSURE WAS PLACED OVER THIS FOR A COUPLE OF MINUTES AND THEN REEXAMINATION SHOWED THAT THE BRUISING PATTERN OF THE RETROPERITONEUM WAS NOT EXPANDING AND PALPATION ALONG THE PERIPHERY OF THE BLEEDER REVEALED REALLY NO RETROPERITONEAL MASS. WE COULD PALPATE THE PULSE OF THE AORTA AND THAT WAS LATERAL TO THE INCISION. A SPONGE WAS THEN PACKED DOWN OVER TO APPLY PRESSURE; AND AT THIS POINT, THE SIGMOID COLON UP TO THE SPLENIC FLEXURE WAS RUN AS WAS THE SMALL BOWEL AND WE DID NOT FIND ANY INCISIONS IN ANY OF THE BOWEL EXAMINED AND WE EXAMINED ALL OF THE SMALL BOWEL AND THE SIGMOID COLON THAT WAS IN PROXIMITY OF THE SLEEVE PLACEMENT. WE DID NOT BELIEVE THERE IS ANY BOWEL INJURY. ONCE WE HAD RECHECKED AND FOUND THAT THERE WAS NOT ANY EXPANDING BRUISING OR MASS EFFECT. AFTER DISCUSSING WITH THE ANESTHETIST, SHE WAS QUITE STABLE AND SO THE DECISION WAS MADE TO FINISH THE INTENDED SURGERY THOUGH WITH THE LAPAROTOMY THIS WOULD NOW BE DONE AS A TOTAL ABDOMINAL HYSTERECTOMY". PT STATUS: "PT WAS STABLE AND TRANSFERRED TO HOSPITAL PER GBSC POLICY FOR OPEN CASES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII Z-THREAD ACC SYS W/SHLD BID OBTURATOR NONE LZN APPLIED MEDICAL CTB73 1165125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ABDOMINAL HYSTERECTOMY TRAY