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

Model Number	TRANSDUCER X7-2
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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 had an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
A field service engineer replaced the suspect transducer for the customer to resolve the reported articulation issue.A thorough evaluation of the suspect transducer could not reproduce the articulation issue as described by the customer.The probe passed all standard testing and also passed an additional articulation test.The investigation confirmed the transducer was operating as designed with no malfunctions.
Event or Problem Description
A customer reported an x7-2t model transducer had an articulation issue during use.There was no injury associated with this event.

• Brand Name: X7-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11341859
• Report Number: 3019216-2021-10017
• Device Sequence Number: 14289631
• Product Code: ITX
• UDI-Device Identifier: 00884838075177
• UDI-Public: 00884838075177
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132304
• 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: 989605414122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Distributor Facility Aware Date: 01/20/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 04/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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