MAUDE Adverse Event Report: X7-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	TRANSDUCER X7-2
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Event or Problem Description
A customer reported an x7-2t model transducer experienced an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
A thorough technical investigation of the suspect transducer was to be performed; however, the customer decided to retain the device.Both the system and the transducer remain at the customer site with no return anticipated; therefore, no further failure analysis can be performed.If the issue recurs, another complaint record will be generated to further investigate the problem.Customer did not replace device.

• Brand Name: X7-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 10971221
• Report Number: 3019216-2020-00116
• Device Sequence Number: 19072602
• Product Code: ITX
• UDI-Device Identifier: 00884838023987
• UDI-Public: 00884838023987
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: TRANSDUCER X7-2
• Device Catalogue Number: 989605361911
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/14/2021
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1