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

Model Number	7209807
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the connector to the machine broke off.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: this event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; street 1 : 75 s. meridian ave; oklahoma OK 73107
• MDR Report Key: 7534359
• Report Number: 1643264-2018-02054
• Device Sequence Number: 123727
• Product Code: HIH
• UDI-Device Identifier: 10884521749924
• UDI-Public: 10884521749924
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7209807
• Device Catalogue Number: 7209807
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1