(b)(6).Investigation summary: review of the device history record for 00515047500, lot number 63476127, identified no relevant deviations or anomalies.Product examination found that the wire at the base of the hand piece of the unit appeared to have been cut by scissors.This complaint is confirmed.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot and close to combustion.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ capa (b)(4) is in process to directly address customers cutting the battery cable.The root cause for this complaint is that the customer cut the wire, creating a short circuit within the battery pack.This short circuit caused the reported event.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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