[3542]
Patient had left thoracotomy and left pneumonectomy. At end of case anesthesia was unable to extubate patient. Fiberoptic bronchoscopy performed and incision re-0pened. Endobronchial tube inadvertently sutured. Suture cut and endobronchial tube removed. Patient discharged 12/28/91 without complications. Device 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, other, invalid data. Conclusion: no failure detected and product within specification, user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5