MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 7209208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Incomplete Induced Abortion (2213)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

D10 concomitant product: 7209509 - soft tissue shaver plus 7209509 truclear, lot# unknown 72205000 - control unit 72205000 hysterolux, 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.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.

Event Description

Pli 10, 30, 40: 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 j une 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.Pli 20: 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.Of 178 included women, 92 were treated with hysteroscopy.Complications in the hysteroscopy group included: fluid deficit greater than 2500 milliliters with no clinical consequences.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18175540
• MDR Text Key: 328614656
• Report Number: 1282497-2023-00063
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521746664
• UDI-Public: 10884521746664
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209208
• Device Catalogue Number: 7209208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female