"ON (B)(6) 2006, A PT WAS INJURED DURING A LAPAROSCOPIC SPLENECTOMY. TWO DEVICES WERE UTILIZED DURING THE COURSE OF THE SURGERY; NAMELY, A GYNECARE X-TRACT TISSUE MORCELLATOR AND A COOK UROLOGICAL, INC. LAPSAC SURGICAL TISSUE POUCH. IT WOULD APPEAR FROM OUR PRELIMINARY INVESTIGATION THAT THE TISSUE MORCELLATOR PENETRATED THE BAG AND INJURED THIS PT'S AORTA, VENA CAVA AND BOWEL. SPECIFICALLY, THE COOK BAG USED DURING THE SURGERY WAS THE 8X10 POUCH, ORDER NO.(B)(4), LOT. NO. U1551052."
N
Patient 1
A PROPER EVAL CANNOT BE PERFORMED AT THIS TIME, DUE TO THE PRODUCT NOT BEING RETURNED. CURRENTLY WORKING THROUGH THE ATTORNEY TO DETERMINE A DATE TO VIEW THE PRODUCT AT THE HOSPITAL. AT THE PRESENT TIME, THERE HAS NOT BEEN AN INDICATION OF THE FAILURE MODE AND NOTHING STATING WHICH IF EITHER DEVICE FAILED. PRODUCTS FROM INTERNAL STOCK WAS PULLED AND EVALUATED ENSURING SEALS ARE INTACT NOTING THE PRODUCTS TO BE WITHIN SPECIFICATION. NOTHING WAS VIEWED THAT COULD HAVE POTENTIALLY CAUSED THIS TYPE OF INCIDENT. AS INFO BECOMES AVAILABLE, IT WILL BE PROMPTLY FORWARDED.