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

Model Number	72204752S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/18/2018
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, during testing, the unit was broken.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one device sample was received for evaluation.This device has been used in the treatment or diagnosis of a patient.The returned sample did not meet specification as received.A visual inspection showed the sheath is dented and broken, spectral colors on the image bundle and aperture, and the outer tube needs to be replaced.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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: 7267152
• Report Number: 1643264-2018-02017
• Device Sequence Number: 11291927
• Product Code: HIH
• UDI-Device Identifier: 10884521746695
• UDI-Public: 10884521746695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152143
• 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
• Report Date (Section B): 06/19/2018

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 Expiration Date: 03/29/2019
• Device Model Number: 72204752S
• Device Catalogue Number: 72204752S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1