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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)
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COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number 72202536
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/15/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, after cervical polyp removal, the patient had large arterial hemorrhage for more than 500 cc.There were no problems during the surgery and the surgery was completed, but the issue occurred the next morning.There were no product abnormalities during the surgery and no tissue damage, but the bleeding points were entered into the cervical canal from the main part of the left cervical artery via the ascending branch.Around area scraped by the shaver near the internal cervical os.Treatment was attempted by securing a balloon etc., but was not effective at all.Hemostasis was performed via uterine artery embolization (uae) treatment in the evening.No transfusion of blood.
 
Manufacturer Narrative
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.
 
Event Description
According to the reporter, after cervical polyp removal, the patient had large arterial hemorrhage for more than 500 cc.There were no problems during the surgery and the surgery was completed, but the issue occurred the next morning.There were no product abnormalities during the surgery and no tissue damage, but the bleeding points were entered into the cervical canal from the main part of the left cervical artery via the ascending branch.Around area scraped by the shaver near the internal cervical os.Treatment was attempted by securing a balloon etc., but was not effective at all.Hemostasis was performed via uterine artery embolization (uae) treatment in the evening.No transfusion of blood.Patient was not on any medication, no active bleeding after the patient was discharge from the operating room and was not performed after the device was used.Patient had no problem after hemostasis.
 
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Brand Name
TRUCLEAR
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN MANSFIELD
15 hampshire street
mansfield MA 02048
MDR Report Key11543627
MDR Text Key241486771
Report Number1282497-2021-00019
Device Sequence Number1
Product Code HIH
UDI-Device Identifier10884521744080
UDI-Public10884521744080
Combination Product (y/n)N
PMA/PMN Number
K130215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72202536
Device Catalogue Number72202536
Was Device Available for Evaluation? No
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age40 YR
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