[16366792]
On 3/27/92, a 25 year old female was admitted for laparoscopic evaluation and management of infertility. The patient's medical history included a spontaneous abortion, three year history of infertility, irregular menses and pelvic inflammatory disease. Under general anethesia, attempted hysteroscopy, laser laparoscopy,lysis of pelvic adhesions, and chromotubation were performed with heraeus laseresonics surgical laser and eder instrument company laser laparoscope. Operative findings were (r) fallopian tube occlusion and extensive, thin as well as thick, pelvic adhesions. Approximately thirty-six hours post-op, the patient was returned to the or for exploratory laparotomy and management of post-laparoscopy intra-ab dominal bleeding. Approximately two liters of clotted and unclotted mesosalpinx and along the (l) lateral wall were repaired. No active site of bleeding was identified; generalized oozing along the rented areas was observed. The patient was discharged in stable condition 4/4/92. She is to be followed-up by her gynecologist. Per her physician, the likelihood of her conceiving is slim. This situation is not related to the occurrence being reported; it is related to her pre-procedure physical condition and operative findings during procedure performed on 3/27/92device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: manufacturer. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, computer hardware performance tests conducted, computer software performance tests conducted, electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated, no failure detected and product within specification, there was no device failure, none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device temporarily removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5