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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
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
Evaluation of the transducer confirmed the articulation issue as described by the customer.Functional testing of the device noted failure of the image and articulation tests.Visual inspection noted corrosion in the connector, a loose distal nut, and a scratched window.Destructive testing identified the steering cable pulled from the solder joint which resulted in the loss of articulation.The failed transducer was replaced by the philips service engineer at the customer site and no similar issues have been reported post repair.

• Brand Name: X7-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11322810
• Report Number: 3019216-2021-10007
• Device Sequence Number: 4124834
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: 00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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?: Yes
• Distributor Facility Aware Date: 02/02/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 04/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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