H3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.Visual inspection noted that after disassembling the device noted cracks on the oled screen.When the device was powered on, the screen stayed black.Functionally, the handle was placed on a charger and allowed to charge.When the handle was removed from the charger, the unit successfully passed motor test, but the screen did not illuminate.The device tested satisfactorily on the a1 test fixture and was able to rotate and articulate a reload without issues.The rear handle housing was removed and damage to the oled (organic light-emitting diode) screen and ir (infrared) shield was found.The handle had 292 of 300 procedures remaining.A review of the system logs showed evidence of a memory verification failure.It was reported that the display screen turned off unexpectedly.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the device is dropped.The evaluation detected an unreported condition: a damage was present on the external component of the handle.The most likely cause could not be established from the information available.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the power handle is a precise instrument.Care should be taken to avoid dropping, improper cleaning, improper handling or sterilizing the device.These actions may shorten device life and/or lead to device failure.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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According to the reporter, preoperatively, the handle was dropped, creating a crack in the screen.The device would not turn on.When removed from the charge, an error tone was heard.Another handle was used to resolve the issue.There was no patient involvement.Medtronic's initial evaluation of the incident device found memory fence error.
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