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

Model Number	7209807S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/08/2018
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, pre-operatively, the unit's coating/inside was chipping off and was missing.No patient involved.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The visual inspection found no notable conditions.The investigation found that the hand piece was flushed out with about 400ml of water and there were no signs of paint chips or flakes.The hand piece was inspected for chips and missing paint and there was no missing paint or chips observed.The external and internal housing of the hand piece was observed and there were no additional anomalies observed.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 city OK 73107
• MDR Report Key: 8127537
• Report Number: 1643264-2018-02068
• Device Sequence Number: 13514043
• Product Code: HIH
• UDI-Device Identifier: 10884521749900
• UDI-Public: 10884521749900
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 7209807S
• Device Catalogue Number: 7209807S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1