Model Number WB91051W |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to the olympus repair center.During inspection and testing, the reported e433 error was confirmed.The issue was isolated to a defective diode (tvs).The cause of the defective diode is unknown.However, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
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Event Description
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The olympus account manager reported the loaner high frequency electro-surgical generator had an e433 error.The reported issue was found at an unspecified event, and there was no report of death, injury or infection and no person or other was affected.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section g2 was corrected to accurately indicate the report source as a healthcare professional.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of error e433 was the destroyed transformer of the generator board.An improved design of the generator board was introduced into production from the beginning of july 2020, after the device was manufactured.Additional information about the event was requested, but not received.If additional information is received, another supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
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Manufacturer Narrative
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Correction: d3, g1, h11.This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3003724334.
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Search Alerts/Recalls
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