BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSUFFLATION & ACCESS NEEDLE

    MDR report key: 279690 · Received May 30, 2000

    Report

    Report Number
    1721520-2000-00002
    Event Type
    Injury
    Date Received
    May 30, 2000
    Date of Event
    April 26, 2000
    Report Date
    May 30, 2000
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON WEDNESDAY, 4/26/2000, PRELIMINARY INFO WAS RECEIVED BY THE INNERDYNE, INC., QUALITY COMPLIANCE DEPT REGARDING ONE INCIDENT INVOLVING A VERESS NEEDLE AND A STEP EXPANDABLE SLEEVE. NUMEROUS SUBSEQUENT FOLLOW-UP ATTEMPTS WERE MADE, CONTACT WAS EVENTUALLY ESTABLISHED WITH DR WHO CONFIRMED THE REPORTED EVENT. THE EPISODE OCCURRED ON 4/19/2000 AT CHILDREN'S HOSP DURING A LAPAROSCOPIC-ASSISTED APPENDICOCECOSTOMY UNDER THE HAND OF DR. THE UMBILICAL PORT WAS PLACED WITHOUT INCIDENT. DURING PLACEMENT OF THE SECOND PORT IN THE RIGHT UPPER QUADRANT, UNDER DIRECT VISION, SEVERE AND SUBTANTIATED ADHESIONS WERE OBSERVED, AND THE VERESS NEEDLE/SLEEVE PASSED INTO THE COLON (THROUGH AND THROUGH) BEFORE THE PHYSICIAN REALIZED THAT THE PERFORATION HAD OCCURRED. DR NOTED THAT THERE WAS NO PRODUCT FAILURE AND THAT IN DR'S OPINION THE BOWEL PERFORATION OCCURRED AS THE RESULT OF THE SIGNIFICANT OR SEVERE ADHESIONS. THE PT HAD NO PRIOR ABDOMINAL SURGERY, DR BELIEVES THE PT HAD SUFFERED PERITONITIS OR SIMILAR CONDITION, WHICH MAY ACCOUNT FOR THE ADHESIONS. AFTER REALIZING THE INADVERTENT PUNCTURE, DR REMOVED THE NEEDLE AND ENLARGED THE SITE ENOUGH TO GAIN ACCESS AND FACILITATE SUCCESSFUL REPAIR OF THE COLON. AFTER REPAIRING THE COLON THE PHYSICIAN PROCEEDED TO PLACE THE SECOND PORT BACK IN AND CONTINUED TO PLACE A THIRD PORT IN ORDER TO COMPLETE THE PROCEDURE LAPAROSCOPICALLY. THE PT LATER DEVELOPED A POSTOPERATIVE BOWEL OBSTRUCTION, UNRELATED TO THE INITIAL BOWEL PERFORATION, WHICH REQUIRED AN ADDITIONAL LAPAROTOMY. THE PT IS REPORTED TO BE DOING FINE AND WILL BE RELEASED FROM THE HOSP TOMORROW 5/31/2000. THE EXTENDED HOSP STAY IS AGAIN UNRELATED TO THE BOWEL PERFORATION BEING CAUSED BY OTHER PREVIOUSLY MEDICAL CONDITIONS. THEREFORE, THE EVENT IS REPORTED AS AN INADVERTENT PT INJURY, FOR A BOWEL PERFORATION AND THE SECONDARY SURGICAL INTERVENTION, ABOVE AND BEYOND THE ORIGINAL PROCEDURE. THE INVOLVED PRODUCT IS NOT AVAILABLE, AND WILL NOT BE RETURNING TO INNERDYNE, INC., THEREFORE, AN INVESTIGATION OF THE PRODUCT HAS NOT BEEN PERFORMED, AND EVALUATIVE CONCLUSIONS CANNOT BE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATION & ACCESS NEEDLE ACCESS NEEDLE GCJ INNERDYNE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization