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

Model Number 72202536

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

Patient Problems Perforation (2001); Injury (2348)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, when the device was being used to sample the tissue inside the cavity during hysteroscopy dilation and curettage, it perfed the uterus leading to a exploratory lap and mini lap.The surgical time extended 30 minutes or more due to the product problem.In order to resolve the issue, they changed the hysteroscopy case to a mini laparoscopic case to complete the procedure.It was reported that there was a temporary superficial bowel injury and a bowel repair was needed to prevent a permanent impairment of function.

• 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 ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7318256
• MDR Text Key: 101658949
• Report Number: 1643264-2018-02023
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 03596010654144
• UDI-Public: 03596010654144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/06/2018

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: 72202536
• Device Catalogue Number: 72202536
• Device Lot Number: 3953919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/06/2018
• 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