According to the reporter, during a total lap hysterectomy, after activation for around half an hour, the active jaw became loose, also the device did not show any activation, no piece was detached from the device.The dissector was immediately replaced with another device and the surgery was completed successfully.There was no patient injury.Medtronic's initial evaluation of the incident device found the jaw liner was melted and there were missing pieces that were not returned.
|
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a jaw liner detachment failure.It was reported that the device received a red light and would not activate during use, and the device had a loose component.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the device jaws was clamped and activated multiple times with too little or no tissue present in the jaws.Extended activation under this condition will cause the jaw liner to melt and become damaged.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: do not to activate the instrument with the clamping jaw closed unless there is tissue present, as doing so may damage the device jaws.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.
|