[3020]
Md using speculum in place for about an hour due to extensive bleeding. Md used different methods to reduce and end bleeding and needed speculum in place for frequent exams and visualization. The patient reported feeling a warm spot "like a finger on a stove". The exam showed a reddened area without blistering in the vagina. Md aware. Speculum pulled from service for evaluation without failure. Tested within speculations. The hulb will get warm with extended time on; but was tested up to 4 hours on. Due to bleeding this may have magnified the degree of warmth but was warrentted due to patient's bleeding statusdevice not labeled for single use. Patient medical status prior to event: fair 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: electrical tests performed, mechanical tests performed, visual examination. Results of evaluation: none or unknown, other, other. Conclusion: device evaluated and alleged failure could not be duplicated, no failure detected and product within specification. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5