The customer reporting during a transurethral resection of the prostate (turp), while using a bipolar device to resect on cautery and cut, it stopped working.The patient was bleeding when the malfunction happened.The staff turned the subject device off and on and it kept cycling with error code e433 "auto-restart.Contact oly." when the biotechnician got to the room, the device would not turn on.Per the technical guide, the error code is associated with an "internal hardware error" and the facility was advised to return the device to olympus for service.No additional information available.
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, the likely causes for the occurrence of the reported error message (e433) are as follows: 1.Malfunction of the esg-400 due to interspersed electromagnetic interference fields (temporary error).2.The user operates the footswitch while the generator is booting (temporary error caused by the user).3.Defective foot switch (temporary error).It should be mentioned that this issue was addressed under capa 147p-017 which was implemented on 30 march 2015.4.Defective foot switch (temporary error, defective reed contact).5.Defective cable connection between the hvps board and generator board (temporary or permanent error).6.Defective cable connection for the output signal between the generator board and relay board (temporary or permanent error).7.Defective current transformer on the generator board (permanent error).8.Defective impedance transformer on the generator board (permanent error).9.Defective peak rectifier on the generator board (permanent error).10.Insufficient output voltage due to poorly switching hf output stage on the generator board (permanent error).11.No or insufficient supply voltage from the hvps board (permanent error).12.Defective motherboard (ntc1, permanent error).13.Defective motherboard (adc, permanent error).14.Defective tvs diodes on the relay board (permanent error).Furthermore, if the error message e433 occurs only sporadically (temporarily), then no further action is necessary.In general, in the case of permanent error patterns, it can be assumed that only one component is faulty.This supplemental report includes a correction to e1 from initial medwatch.Also, information added to e2, e3 and g2.Olympus will continue to monitor field performance for this device.
|