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

Model Number 72202536-

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fainting (1847); Pain (1994); Perforation (2001)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

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, post operatively, the patient was released and later brought to er with shortness of breath, fainting and pain behind ribcage.During in-office procedure of operative hysteroscopy with removal of retained poc (product of conception), doctor observed possible perforation.Cavity remained distended, there was no visualization issues.Ultrasound showed free fluid in patient's abdomen.The patient was treated and kept overnight.

Manufacturer Narrative

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

Event Description

According to the reporter, as per the additional information received, there was possible perforation of cervix.There was blood loss more than 500cc but not caused by product, rather upon dilation of cervical canal.Patient did receive blood transfusion.Patient went to emergency room and later to or for exploratory laparoscopy.Surgical intervention was needed to prevent a permanent impairment of a function.Patient brought to or for exploratory laparoscopy and fluid drained from abdomen to resolve the issue in order to complete the case.The current status of the patient- well.Patient¿s past medical history: pregnancy, abnormal uterine bleeding.

• Brand Name: TRUCLEAR INCISOR
• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6911286
• MDR Text Key: 88043714
• Report Number: 1643264-2017-21110
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: 72202536-
• Device Catalogue Number: 72202536-
• Device Lot Number: E68813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/16/2017
• 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): Other
• Patient Age: 30 YR
• Patient Weight: 50