The anspach drill intended for treatment was returned for evaluation.The reported problem was confirmed.The hose was completely torn 30" from the drill end, revealing the underlying conductors.Although the reported problem was visually confirmed, a functional evaluation was performed on the part beyond the reported complaint the evaluation followed pv0005 rev.B.The evaluation failed.The drill was running extremely hot to the touch.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the part with the failure modes ¿material split, cut or torn¿ and ¿damaged cord¿ identified similar events.The most likely cause of this event is improper handling.Care and caution should be exercised during the surgical site setup and tear down to protect the device cable and from sharp objects or from situations that pin the cable between two objects.Do not use excessive force on the device strain reliefs during the decontamination process to minimize separating the cable from the strain relief.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.The most likely cause of the overheating is mechanical failure of the drill motor shaft.The drill is an oem part and cannot be further disassembled to determine a root cause based on the investigation, no further containment or corrective action is recommended or required at this time.(case-(b)(4)).
|