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

Model Number 7209208

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

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Title removal of endometrial polyps: hysteroscopic morcellation versus bipolar resectoscopy, a randomized trial source journal of minimally invasive gynecology, vol 22, no 7, 2015.Date of publication: 08 jul 2015.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

During a study to compare hysteroscopic morcellation with the tissue removal system verses bipolar resectoscopy for removal of endometrial polyps; perforation occurred at dilation in 1 patient in the hysteroscopic morcellation group; however, the procedure was successfully completed.Additionally, 2 patients of the hysteroscopic morcellation group were diagnosed with a urinary tract infection post operatively.

• 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: 7819612
• MDR Text Key: 118326968
• Report Number: 1643264-2018-02058
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521746664
• UDI-Public: 10884521746664
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K013870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2018

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: 7209208
• Device Catalogue Number: 7209208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/27/2018
• 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): Required Intervention