BEUDAMED
    FDA Adverse Event Death Summary report: N

    KII SHIELDED BLADED TROCAR

    MDR report key: 8603877 · Received May 3, 2019

    Report

    Report Number
    8603877
    Event Type
    Death
    Date Received
    May 3, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 3, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR AN ELECTIVE HYSTERECTOMY BUT AT THE START OF THE PROCEDURE EXPERIENCED A TROCAR INJURY TO THE SMALL BOWEL, AORTA AND INFERIOR VENA CAVA CAUSING HEMORRHAGE WITH SUBSEQUENT COAGULOPATHY AND ORGAN FAILURE. PT EXPIRED THE FOLLOWING DAY. AT THE START OF THE PROCEDURE, THE PRIMARY GYNECOLOGICAL SURGEON MADE A 10MM INCISION JUST ABOVE THE UMBILICUS AND THE SKIN WAS SPREAD USING A HEMOSTAT. THEREAFTER A 12 X 150MM BLADED TROCAR WAS INTRODUCED INTO THE ABDOMEN USING DIRECT ENTRY TECHNIQUE. ONCE INTRA-ABDOMINAL PLACEMENT WAS CONFIRMED AND PNEUMOPERITONEUM WAS COMPLETE AT A PRESSURE OF 15MM HG IT WAS NOTED THAT THERE WAS SOME BLEEDING AROUND THE SMALL BOWEL. IT WAS A LITTLE MORE THAN EXPECTED THEREFORE AN ASSIST PORT WAS PLACED IN THE RIGHT LOWER QUADRANT FOR FURTHER ASSESSMENT. IT WAS NOTED THEN THAT THE BLEEDING WAS BRISK AND POSSIBLY RETROPERITONEAL SO THE LAPAROSCOPIC PROCEDURE WAS ABORTED AND CASE WAS CONVERTED TO OPEN. A PFANNENSTIEL INCISION WAS MADE WITH THE SCALPEL DOWN TO THE FASCIA. FASCIA WAS INCISED AND THE ABDOMEN WAS ENTERED BLUNTLY. THE PT EXPERIENCED CARDIAC ARREST FOR WHICH CPR / ACLS WAS INITIATED. GENERAL SURGERY WAS EMERGENTLY CONSULTED AND WAS IMMEDIATELY AVAILABLE TO ASSIST IN STABILIZING THE PT. VASCULAR SURGERY ALSO PROVIDED INTRA-OP CONSULATING FOR REPAIR OF INJURIES TO THE AORTA AND INFERIOR VENA CAVA FOLLOWED BY GENERAL SURGERY'S REPAIR OF THE VENTILATOR SUPPORT, HAD METABOLIC ACIDOSIS, COAGULOPATHY, ANURIA AND CONTINUED OOZING FROM THE SURGICAL SITE. THE FOLLOWING DAY, PLAN WAS TO RETURN PT TO SURGERY FOR ABDOMINAL WASHOUT, DECOMPRESSIVE LAPAROTOMY FOR SUSPECTED ABDOMINAL COMPARTMENT SYNDROME BUT PT EXPIRED PRIOR TO START OF SURGERY. THE INCISION WAS JUST ABOVE THE UMBILICUS, APPROPRIATE FOR THIS PT. DURING TROCAR INSERTION, THERE WAS NO UNUSUAL RESISTANCE OR EXCESSIVE PRESSURE APPLIED RELATED TO FIRM ABDOMEN / FASCIA AS EXPECTED IN A PT WITH PRIOR ABDOMINOPLASTY. THE BLADE FELT TO RETRACT AS DESIGNED WHEN GOING THROUGH FASCIA WITH NO INDICATION OF PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    USE OF A BLADED TROCAR IS ACCEPTABLE AND COMMON PRACTICE. THE SURGEON USED HIS STANDARD PRACTICE OF RAISING THE ABDOMINAL WALL WITH 2 TOWEL CLAMPS TO TENT THE ABDOMEN THEN INSERTING THE BLADED TROCAR VIA BLIND STAB TECHNIQUE WITHOUT USE OF VERESS NEEDLE INSUFFLATION. THE PT HAD A HISTORY OF ABDOMINOPLASTY WHICH WAS KNOWN TO THE SURGEON AND DID NOT SEEM TO CONTRIBUTE TO THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371699 KII SHIELDED BLADED TROCAR 12 X 150MM BLADED TROCAR GCJ APPLIED MEDICAL RESOURCES CORP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death