BEUDAMED
    FDA Adverse Event Other Summary report: N

    1721520-1999-00010

    MDR report key: 257143 · Received December 28, 1999

    Report

    Report Number
    1721520-1999-00010
    Event Type
    Other
    Date Received
    December 28, 1999
    Date of Event
    December 2, 1999
    Report Date
    December 28, 1999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON THURSDAY, DECEMBER 2, 1999, PRELIMINARY INFO WAS REC'D BY THE INNERDYNE, INC, QUALITY COMPLIANCE DEPT REGARDING ONE (1) INCIDENT INVOLVING A 10MM DILATOR FOR THE STEP PRODUCT. DEFINITIVE AND CONFIRMING INFO WAS REPORTED ON THURSDAY, DECEMBER 23, 1999 BY INNERDYNE, INC SALES REP REGARDING THIS INCIDENT TO THE REGULATORY AFFAIRS DEPT OF THE CO. THE EPISODE OCCURRED AT SURGERY CTR DURING A LAPAROSCOPIC PROCEDURE UNDER THE HAND OF DR. IN 1999, A GYNECOLOGICAL LAPAROSCOPIC PROCEDURE WAS UNDERTAKEN BY THE PHYSICIAN. THE PT PRESENTED A HISTORY OF PRIOR ABDOMINAL SURGERY, SO THE ATTENDING PHYSICIAN USED A "CUT DOWN" TECHNIQUE AND INSERTED THE SLEEVE WITHOUT A NEEDLE, WHEREUPON THE SLEEVE APPEARED TO DEFLECT, NOT MAINTAINING PLACEMENT UPON INSERTION. THE SLEEVE WAS THEN DILATED TO 10MM AND A CAMERA WAS INSERTED, BUT VISUALIZATION WAS NOT ACHIEVED. THE SLEEVE AND CAMERA WERE REMOVED AND A FINGER SWEEP WAS PERFORMED, WITH ALL APPEARING CLEAR. UPON INSUFFLATION, THE ABDOMEN APPEARED TO DISTEND NORMALLY. THE NEEDLE WAS REMOVED, SUBSEQUENT DILATION TO 10MM WAS SECURED, FOLLOWED BY RE-INSERTION OF THE CAMERA. VISUALIZATION, AGAIN, COULD NOT BE OBTAINED, WHEREUPON THE CAMERA WAS REMOVED, THE DILATOR RE-INSERTED, AND THE CANNULA/DILATOR COMBINATION WAS REMOVED. UPON REMOVAL OF THE LATTER, BOWEL CONTENTS CONTAMINATION WAS NOTED. THE PT WAS CLOSED, THEN TRANSFERRED TO HOSP FOR OPEN LAPAROTOMY & BOWEL REPAIR. SURGERY CTR WAS CONTACTED FOR STATUS/CONDITION OF THE PT. THE PT WAS REPORTED TO BE DOING FINE. THEREFORE, THE EVENT IS REPORTED FOR THE POSSIBILITY OF PERFORATING THE BOWEL WITH THE STEP DILATOR AS REPORTED BY DR. SECONDARY SURGICAL INTERVENTION, ABOVE AND BEYOND THE ORIGINAL PROCEDURE, WAS UNDERTAKEN. THE INVOLVED PRODUCT HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR RETURN TO INNERDYNE INC SO AN INVESTIGATION OF THE PRODUCT HAS NOT BEEN POSSIBLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention