Model Number WB91051W |
Device Problem
Energy Output Problem (1431)
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Patient Problems
Injury (2348); Patient Problem/Medical Problem (2688)
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Event Date 06/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device was returned to the service center for evaluation.The unit was inspected and tested.All tests passed.All outputs are within specifications.Errors e006 and e486 are recorded in the error log multiple times, but were not duplicated during inspection.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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User facility reported that following a transurethral resection of the prostate (turp) on (b)(6) 2020, patient presented the next day with bleeding.During the initial surgery, the doctor used an electrode loop and was working on the left side of the prostate.When that was dry he moved to the right side of the prostate, and noticed that the image was getting bloody.At that point it was identified that the left side of the prostate started bleeding again.It is understood that there was no bleeding present upon completion.The patient returned due to bleeding.The doctor completed the surgery again, and found that the left side of the prostate was bleeding.
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Manufacturer Narrative
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This report is being submitted to report investigation findings.Device history review (dhr): a manufacturing and quality control review was performed for the affected lot number without showing any non-conformities or deviations regarding the described issue.Analysis: errors e486/e619 occur when the generator is activated in the first 2 seconds after the instrument has been connected.In these 2 seconds, the instrument should be recognized by the device.However, when the generator is activated in this time, the instrument recognition is not completed and the error message is displayed.In this case, this error is a user¿s fault and not a permanent error.Error e006 is triggered due to an increased impedance between both electrodes.Possible causes are: increasing deposits of tissue on the electrode.Increased contact resistances due to incorrect or insufficient connected plugs.Increased contact resistances due to defective contacts.The measuring method of the esg-400 might have an impact on the conductivity.Conclusion: the cause for the reported error codes cannot definitely be determined.In this case, possible causes for this error are: a hardware defect on the motherboard.Readout problems during the instrument recognition.If error e486 also occurs with other instruments, a hardware defect very likely causes this error.
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Search Alerts/Recalls
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