According to the reporter, during closure of the cervix after removal of uterus on a laparoscopic subtotal hysterectomy with debulking of uterus and bilateral salpingectomy, the patient had a very thick cervix, which had complicated removal of the uterus prior to using the endostitch.During the first bite taken with the instrument, the needle did not make it through the thick cervix, and broke off and fell into the patient's cavity.The tip of the needle is believed to still be in the endostitch device.The remainder of the needle and attached suture were retrieved with graspers and removed laparoscopically.Another device was used to complete the case.There was no patient injury.
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Additional information: d10, g4, h3, h6.H3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned instrument noted that there were no a bnormalities that would have caused or contributed to the reported condition.In addition pmv performed a photographic evaluation of one image and the visual inspection of the returned photo noted that the instrument jaws were closed and one of the blades were slightly advance.The returned instrument was found to function properly and the test needle remained intact.No difficulty was experienced in loading, unloading or toggling the test needle in the returned instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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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