Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Quality personnel tested attachment and found it met all temperature parameters as per pds 8019.Upon disassembly and examination, the internal main drive and head components all exhibited slight to moderate wear and/or debris.Head and main drive gear assemblies were dry.The contact between the set pusher and the cap underside could have caused the heat stated in the original complaint.
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