It was reported that the circumcision device would not screw down far enough during a circumcision to prevent the penis from bleeding.The doctor stated that he screwed the device down as tight as he could, and when he removed the device the penis bled.Pressure had to be applied and the doctor put a surgical absorbable hemostat on the area to control the bleeding.There was no additional medical intervention required and the baby was reportedly doing fine.Un-used samples were returned to the manufacturer for evaluation it was determined that the facility was disassembling and sterilizing the device in an autoclave prior to use against manufacturer instructions.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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