[6870]
On 6/28/94 pt to treatment room for colonoscopy with possible polypectomy. Polyp located and physician inserted disposable snare into scope. Polyp snared and when physician attempted to cut/cauterize polyp there was no current. Connections and grounding pad checked and found to be satisfactory. Procedure was stopped. Cautery unit sent to biomed department for evaluation. Snare was found to have a "pinched" portion up near the handle. Biomed staff stated area could be problem area. Biomed department tested cautery unit using same snare for approx four hours. Could not reproduce reported problem. Pt returned to treatment room on 7/7/94. Colonoscopy performed and polyp bleeding site cauterized with same cautery and different snare. Procedure satisfactory. Device 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-94. Service provided by: user facility biomedical/bioengineering department. Service records available. 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, electrical 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, none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5