During inspection and testing, the jaw symmetry was unbalanced and the jaws were misshaped.The device was received with the jaws opened, lock on.A visual inspection indicated that there was minor dried tissue on the jaws consistent with use.Additionally, the jaws and jaw teeth had visible scuff marks, along with bent jaw teeth closer to the distal end.The first point of contact for the jaws was at the distal end; this is consistent with standard.The jaws would not completely close when using the lock function, after releasing the forceps grip.Additionally, a test gyrus g400 generator was used in conjunction with the 920005pk hand piece and it was confirmed that energy was transferred to the distal end during activation which was visually represented by vapors of moisture during contact with the wet cotton pad when the foot pedal was activated.This was performed multiple times while adjusting output indicating the device was working properly.A review of the device history record found no deviations that could have caused or contributed to the misaligned jaws.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, the device's coagulation features operated as intended.However, as there were signs of usage, the observed failure is a known phenomenon likely resulting from using the device through resistance and/or putting excess stress on the device's distal tip.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "keep the device tip in sight during use.Inadvertent activation or movement of the device outside the field of vision may result in patient injury." olympus will continue to monitor field performance for this device.
|