According to the reporter during the umbilical hernia repair via laparoscopic procedure, while taking down adhesions and then attempted to insert the device and it would not lay flat.The surgeon took the device out and tried again for that same piece.Then opened another device and tried it again still with the same condition.There was an extended surgical time of 30 minutes or more and to complete the case, the surgeon opened a new one with a different size that worked.There was no patient injury.
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Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the product was used outside the instructions for use (ifu) specifications.The pgla expanders were broken perpendicular to the direction of folding.It was reported that the mesh was difficult to adhere, did not stay in place, or shifted within the patient while being implanted.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: fold the hydrated composite ventral patch in half along the junction of the two violet expanders.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.
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