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According to the reporter, at the second or third firing to close the cystic duct during a laparoscopic cholecystectomy, a strange sound was heard and the surgeon could not fire the clip.Another device was used but the same issue occurred.A third device was used and completed the closure of the cystic duct and vessels.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 that the handle was broken and out position, in a manner consistent of cycling through the safety interlock.The instrument was partially fired with seventeen clips remaining.No other visual abnormalities were observed.Functional evaluation found that the jaws did not close upon actuation of the handle.The safety interlock channel lugs were also broken.Due to the condition of the instrument, further functional evaluation was not performed.It was reported that the clips did not load properly into the jaws as expected, and the device gave unexpected or uncharacteristic audible feedback of normal use.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This can occur when an attempt is made to fire the instrument without first loading a clip by using the trigger.The safety interlock feature is designed to prevent the jaws from closing on a vessel in the absence of a loaded clip.If an attempt is made to forcibly fire the instrument while engaged in interlock, the lugs are designed to break as noted and the interlock feature continues to function as intended.The manufacturing records for each device are also 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.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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