D10 concomitant product: 72205000 - control unit 72205000 hysterolux, serial# unknown 7209208 - 7209208 truclear 8.0mm op hysteroscope, serial# unknown 72204879 - hysteroscope plus 72204879 truclear, serial# unknown.Literature events: author: liselot p.Wagenaar, hubertus a.Van vliet, celine m.Radder, louisette w.Peters, steven weyers, benedictus c, schoot, tjalina w.Hamerlynck title: operative hysteroscopy versus ultrasound-guided electric vacuum aspiration for removal of retained products of conception: a prospective cohort study date published: 24 august 2023 source: https://doi.Org/10.1016/j.Eurox.2023.100230.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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According to the literature, a prospective study compared intrauterine adhesion formation in patients who underwent hysteroscopic removal of retained products of conception or ultrasound-guided electric vacuum aspiration between april 2015 until june 2022.Hysteroscopic removal was performed with the truclear 8.0 system or elite hysteroscope plus with a soft tissue shaver plus or a competitor device.Fluid balance was monitored using the hysterolux or a competitor device.Hysteroscopes were inserted under direct vision after dilating the uterine cervix with dilators.Of 178 included women, 92 were treated with hysteroscopy.Complications in the hysteroscopy group included hemorrhage, perforation, persistent retained products of conception, and adhesions.Conversion to vacuum aspiration was required due to hemorrhage (greater than 500ml) and bad visibility ± poor distention/rapid fluid loss.Perforation occurred at the cesarean scar which had minimal myometrium overlay, and resulted in a small bladder perforation which was confirmed with cystoscopy and treated with a bladder catheter for 10 days.Repeat hysteroscopy was required for patients with persistent retained contents and adhesions.Postoperative hemorrhage required rehospitalization and treatment with curettage.
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