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End customer was using the 231 cautery to complete an in-office circumcision.During the procedure: the cautery was used outside the body.The procedure was completed without any supplemental procedures.The cautery was being used for 1-2 seconds activated and 15 seconds relaxed in a cyclic pattern.The burn occurred on the side of the physician's glove and the paper drape.The paper drape did cause a small burn to the patient, but was not sever to require any medical attention.No separate medical attention was pursued for both patient and physician.The product was received for evaluation on 6/12/2019.The product received was of new product from the same lot number.The product involved in the case was not returned.The returned product from the same lot number was tested for voltage measured at the tip with a multimeter 20250-53 with serial number (b)(4).The products measured between 1.91v-2.14v.The voltage correlated to the temperature using bovie vp-0147 measured between 2,306.50-2,469.99 fahrenheit.This voltage and temperature are within normal range for the product specification.Additionally, the dhr (device history record) for the lot number involved was reviewed.There were no related non-conformities noted during manufacturing and processing of the product.All items were noted to be within manufacturing specifications from the manufacturer.Based on the testing completed and the review of the history file, it can be determined that the product that the customer received was within specifications.A true root cause is undetermined, however, it the most probable cause is from misuse while using the device.This report can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions a follow-up report will be submitted.The actual date of the event is unknown.
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