MAUDE Adverse Event Report: MITG - OKLAHOMA CITY TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	72204064
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exsanguination (1841); Blood Loss (2597)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during hysteroscopy, the distention was poor when the device was used.It causes poor visualization and doesn't give the physician the best environment for resecting and aspirating tissue.An emergency hysterectomy was performed to stop the bleeding and spread of potential cancerous tissue within the uterus.The uterus was removed, the bowl was perforated and the iliac artery was compromised that caused permanent injury.There was also a blood loss of 500cc that requires a blood transfusion.This lengthen the procedure to 2.5-3 hours.The patient was transferred to icu for unknown amount of time and the hospitalization was extended.

• Brand Name: TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• MDR Report Key: 7882838
• Report Number: 1643264-2018-02064
• Device Sequence Number: 228661
• Product Code: HIH
• UDI-Device Identifier: 10884521744097
• UDI-Public: 10884521744097
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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
• Operator of Device: Health Professional
• Device Model Number: 72204064
• Device Catalogue Number: 72204064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention