According to the reporter, during laparoscopic procedure for ampullary cancer, while retracting the device, a sharp edge at the distal tip of the black sheath lacerated the right portal artery resulting into emergency laparotomy to stop bleeding.Incision had to be extended by more than 1 inch.Blood vessel was ligated.Blood loss was more than 800 cc and blood transfusion had to be performed.An additional of 1 hour was added to the surgery to repair the damage.
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the sleeve of the instrument was damaged.It was reported that the sheath was damaged, torn, or broken, an incision of >1 inch was needed wherein operating room (or) time was extended by more than 30 minutes, and significant surgical intervention was required due to the product failure.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if excessive manipulation is applied to device when pushing the tip through the sheath.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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