The device was purchased from an unknown order number through our distributor.The customer stated that the cautery was activated for 5-6 seconds at a time with resting cycles of 5 seconds.The cautery was used on 4 different mice for a total of 30 seconds including resting and activation times.The customer stated that the oxygen present at the surgical site caused the fire to spread rapidly.The surgeon received minor burns on the hands and was able to recover without hospitalization.The root cause has been determined to be human error.Most likely from the customer not following the proper duty cycles, reuse of the cautery, and having flammable material close to the cautery activation site.The ifu that is received with the item states the following: do not use in the presence of flammable gases/materials or in oxygen rich environments.Fire could result.This medical device cannot be effectively cleaned and or sterilized by the user and is therefore not safely reused.The recommended duty cycle is 2 seconds on and 6 seconds off for a continuous time of no longer than 15 minutes.The user was informed of the duty cycles and given the ifu for review.A dhr review was completed for the reported lot number.There were no noted nonconformities during manufacturing and processing of this product and lot numbers.All items were noted as within manufacturing specification from the manufacturing location.There has been a total of (b)(4) cauteries sold since 2016 with one additional complaint recorded for a similar occurrence.((b)(4) complaint rate).Based on the above information no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient or user involvement or any need for corrective actions, a follow up report will be submitted.
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