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

Model Number 72202536

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Title: massive hemorrhage after resection of uterine endocervical polyp and endometrial polyps with hysteroscopic tissue removal system.Source: med case rep study protoc 2021;2:9(e0141) accepted: 30 june 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a (b)(6) year-old woman underwent resection of uterine endocervical polyp and endometrial polyps.Truclear system was used to resect endometrial polyps and to morcellate the stalk of the uterine endocervical polyp.The operating time was 32 minutes and blood loss volume during surgery was 1 g.The next morning, 13 hours after surgery, the patient experienced vaginal bleeding and massive hemorrhage from the uterus.Balloon catheter was inserted to stop the hemorrhage but was unsuccessful.Contrast-enhanced computed tomography and uterine angiography were performed.A uterine arterial embolization (uae) was also performed which resolved the bleeding.The patient was discharged three days later.

Manufacturer Narrative

G3, 510k 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

According to the literature, a 47-year-old woman underwent resection of uterine endocervical polyp and endometrial polyps.Truclear system was used to resect endometrial polyps and to morcellate the stalk of the uterine endocervical polyp.The operating time was 32 minutes and blood loss volume during surgery was 1 g.The next morning, 13 hours after surgery, the patient experienced vaginal bleeding and massive hemorrhage from the uterus.Balloon catheter was inserted to stop the hemorrhage but was unsuccessful.Contrast-enhanced computed tomography and uterine angiography were performed.A uterine arterial embolization (uae) was also performed which resolved the bleeding.A blood transfusion was not performed.The patient had no anti-platelet medication and not hypertensive.The patient was also discharged three days later.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13440197
• MDR Text Key: 284964342
• Report Number: 1282497-2022-00003
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202536
• Device Catalogue Number: 72202536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female