[1748]
As dictated by physician in medical recorded:"the patient was taken to the operating room under general anesathesia. The vagina prepped, foley catheter aseeeeptically placed urinary bladder. She was then placed in the supline position, prep and drape in the normal sterile manner, had a well healed lower abdominal transverse incision. Because of the strong suspicion of intestional adhesion formation, as presumed from her previous operative procedures and documented on recent radiographic studies, it was decided that the pneumoperitoneum should be created by inserting the verres needle in the left upper quadrant. Palpatation of the two distal ribs was then made and an incision made with the scapel and the verres needle introduced into the peritoneal caviaty and approximately 3 liters of co-2 introduced to create the pneumoperitoneum. A 5mm cystoscope was then placed just distal to the last rib in the midclavicular line without difficulty and a 5mm cyctoscope was then introduced and exploration of the abdomen revealaed extensive adhesions of the colon to the right pelvic sidewall with what appeared to be a cystic mass down into the pelvis lying high up and attached to the anterior abdominal wall onthe left pelvic sidewall measuring approximately 3cm. It was then decided to proceed with the introduction of the trocar for laparoscope at the level of the umbilicus. At this time it became apparent athat there was some leakage of co-2 and reinspection revealed that there was leakage at the 5mm trocar with the cystoscope and an attempt to place a 3. 5mm reducer would not function, because of the cystoscope not being able to pass through the reducer. Therefore, the cystoscope was then reintroduced through the 5mm trocar. The 10mm trocar was then introduced through the umbilical incision and once it was introduced and the trocar removed,it became apparent that there was in fact, some bleeding over the mid abdomen in an area where the omentum was densely adherent. There did not appear to be a significant amount of bleeding, but there was bleeding noted. In light of this finding and because of the extensive adhesion formation visualized previously, it was then decided that the patient should have an open operative procedure. A low transverse incision was then made with the scapel and a balfour retractor introduced and with adequate exposure it became apparent that there was bleeding retroperitoneally in the lower abdomen at the level just above the bifurcation of the aorta. Because of extensive bleeding, it was then decided that additional surgical help from a general surgeon would be indicated and consultation was obtained fromd a general surgeon who arrived and scrubbed in. Prior to his arrival, athis area of bleeding was controlled with external tamponade and pressure and then subsequent procedure that was performed by the general surgeon is to be dictated by seperate cover. Patient did undergo a cardiac arrest, resuscitative attempt maddevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5