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

Model Number	7209808S
Medical Device Problem Codes	Break (1069); Mechanics Altered (2984)
Health Effect - Clinical Code	No Patient Involvement (2645)
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, during testing, the device would not work and hand piece was broken.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary received one (1) device.The returned sample did not meet specification as received.A visual inspection was performed on the exte rior of product and no physical damage was observed.The reported condition was confirmed.It appears that extreme force was used to remove multi-dwelling unit (mdu) connector on power cord from hand piece receptacle on control unit which caused shaft to break off mdu connector and become stuck inside of hand piece receptacle.The investigation isolated the failure to the receptacle, but a root cause was not identified.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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; 75 s. meridian ave; oklahoma OK 73107
• MDR Report Key: 7479941
• Report Number: 1643264-2018-02043
• Device Sequence Number: 196966
• Product Code: HIH
• UDI-Device Identifier: 10884521749917
• UDI-Public: 10884521749917
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 7209808S
• Device Catalogue Number: 7209808S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 08/08/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 07/18/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1