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Model Number 786500 |
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 06/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not yet been received for evaluation.The cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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It was reported the unit did not work when opened.No energy flowing through the unit.According to the reporter, the user re-seated the unit however, the unit did not worked.User tried another unit and it worked.There was no patient harm, no user injury reported due to the event.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on device return evaluation.The subject device was received and evaluated.The customer returned a pk button electrode model number 786500 lot number u2109087 for the evaluation of "unit did not work when opened.No energy flowing thru the unit." the model and lot number are based on rma paperwork as there is no visible model and lot number on the electrode.A visual inspection on the as is received condition of the device; noted that the electrode was returned along with a orange "supersect/pk button cable.The electrode and cable was not returned in its original packaging.Inspection identified what appears to be a portion of the shaft that is slightly dented and deformed.The distal end as well as the proximal end have no signs of physical damage or anomalies.A functional test was performed by using a test pk frontloading working element model number eiwe-pkfl.The orange t-shaped superpect/pk button electrode cable was inserted into the slot on the base of the white instrument actuator block with no issues.The electrode was inserted into the working element from the front, advancing the proximal end past the locking mechanism and was engaged with a click.Testing verified that the electrode proximal end was securely fastened.The connector of the electrode cable was plugged into a test 744000 gyrus generator and verified that the generator was able to recognize the customer's electrode.The default settings displayed on the generator, sp2 (200) and des(100).The distal end of the electrode was placed on top of a cotton pad soaked in saline.During testing, a test footswitch was connected and pressed on the yellow cut pedal and observed output power being provided through the distal end of the electrode and then pressed the blue coag pedal and again observed power being provided through the distal end of the electrode.The yellow and blue foot pedals were pressed several times observing output power being provided through the distal end of the electrode.Based on the device evaluation it is unable to determine the cause of customer's issue as during testing, output power was observed being provided with this device.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, output power was observed.Therefore, the cause of the customer¿s issue could not be determined.This supplemental report includes information added to e2, g2 and h4.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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