MAUDE Adverse Event Report: MITG-OKLAHOMA CITY TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72202976

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

Patient Problem Vaso-Vagal Response (2661)

Event Type  Injury  

Manufacturer Narrative

Title: hysteroscopic morcellation compared with electrical resection of endometrial polyps source obstetrics & gynecology morcellation vs electrical resection trial.Vol.123, no.4.Date of publication: april 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

Vasovagal reactions were the only adverse events reported and occurred in 1/62 (2%) patient in the hm group and 6/59 (10%) in the electrical resection group.One serious adverse event of endometritis was reported in a patient in the hm group who was admitted for treatment 2 weeks after the procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7834312
• MDR Text Key: 118808984
• Report Number: 1643264-2018-02060
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202976
• Device Catalogue Number: 72202976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/27/2018
• 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): Hospitalization; Required Intervention