BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK SURGASSIST STRAIGHT LINEAR CUTTER DLU

    MDR report key: 1580449 · Received January 8, 2010

    Report

    Report Number
    2532140-2009-00171
    Event Type
    Death
    Date Received
    January 8, 2010
    Date of Event
    September 17, 2003
    Report Date
    December 31, 2009
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE OF BOWEL NECROSIS, NO DEPRIVATION OF BLOOD SUPPLY. AFTER THE RE-OPERATION, THE PT NEVER REALLY RECOVERED; SHE REMAINED SEPTIC. THE FAMILY DIDN'T WANT ANY ESCALATION OF CARE, SO THEY WITHDREW LIFE SUPPORT IN 2003. THE PT'S FAMILY REFUSED POST-MORTEM.

    Description of Event or Problem · 1

    THIS INCIDENT IS BEING REPORTED AFTER A COMPREHENSIVE RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY POWER MEDICAL INTERVENTIONS; THIS INCIDENT WAS NOT PREVIOUSLY REPORTED. COVIDIEN ACQUIRED PMI ON SEPTEMBER 8, 2009. ACCORDING TO THE REPORTER, THE INITIAL PROCEDURE, EXTENDED TRANSVERSE COLECTOMY, WAS PERFORMED IN 2003. THE PMI DEVICES USED ON THE CASE WERE A SLC (STRAIGHT LINEAR CUTTER) WITH DLUS AND RALC (RIGHT ANGLE LINEAR CUTTER) WITH DLUS; THE EXACT INSTRUMENTS AND LOADING UNITS USED WERE NOT RECORDED. AT THE TIME OF THE FIRST PROCEDURE, THE SURGEON STATED THAT THE ANASTOMOSIS LOOKED FINE. THE ANASTOMOSIS WAS TESTED BY MOVING AIR BACK AND FORTH WHILE SALINE WAS DRIPPED ON THE STAPLE LINE; THERE WAS NO PRESENCE OF BUBBLES. THE PT REMAINED IN THE HOSP. THE PT HAD ACUTE ABDOMINAL PAIN AND TWO WEEKS LATER; AN X-RAY SHOWED FREE AIR IN THE BOWEL. THE SAME DAY, THE PT WAS BROUGHT BACK INTO SURGERY. THE SURGEON COMMENTED THAT EVERYTHING LOOKED FINE EXCEPT FOR A 2MM DIAMETER PINHOLE LEAK A THE STAPLE LINE. THE SURGEON PICKED A "B" SHAPED STAPLE OUT OF THE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SURGASSIST STRAIGHT LINEAR CUTTER DLU SURGICAL STAPLER GDW POWER MEDICAL INTERVENTIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death RIGHT ANGLE LINEAR CUTTER (RALC) DLU