Description of Event or Problem · 1
ON MONDAY, 24 NOVEMBER 1997, INFORMATION WAS RECEIVED BY THE INNERDYNE, INC. REGULATORY AFFAIRS DEPARTMENT FROM AN INDEPENDENT SALES REPRESENTATIVE, LUBOCK, TEXAS, REGARDING ONE (1) INCIDENT INVOLVING A STEP PRODUCT. THE EPISODE OCCURRED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE ON A FEMALE PATIENT UNDER THE DIRECTION OF A DR. DURING THE PROCEDURE, THE 10MM STEP RADIALLY EXPANDING DILATION ACCESS SLEEVE WAS PLACED IN THE UMBILICAL REGION AS A PRIMARY PORT UTILIZING CORRECT TECHNIQUE. THE PATIENT WAS A PREVIOUS SURGICAL PATIENT, PRESENTING SIGNIFICANT ANTERIOR ABDOMINAL ADHESIONS. UPON REPLACEMENT OF THE PRIMARY PORT, AN INADVERTENT PERFORATION OF THE BOWEL OCCURRED AS A RESULT OF THE DENSE ANTERIOR ADHESIONS, SUBSEQUENTLY DETECTED VIA SCOPE PLACEMENT, RESULTING IN THE NECESSITY OF REVERTING TO AN OPEN PROCEDURE FOR SURGICAL REPAIR, UNDER THE HAND OF AN ATTENDING GENERAL SURGEON. A 2-LAYER CLOSURE OF THE PERFORATION WAS ACCOMPLISHED WITHOUT INCIDENT, AND THE PROCEDURE WAS COMPLETED VIA THE OPEN ROUTE. THE PATIENT WAS SATISFACTORILY CLOSED, TAKEN TO RECOVERY, AND IS REPORTED FINE AT THIS TIME WITHOUT MEDICAL SEQUELAE. THEREFORE, THE REPORTED EVENT IS DESCRIBED AS AN INADVERTENT PERFORATION OF THE BOWEL REQUIRING SECONDARY MEDICAL INTERVENTION FOR REPAIR. NONE OF THE UTILIZED ITEMS WERE RETURNED OR AVAILABLE FOR EXAMINATION.