MAUDE Adverse Event Report: X8-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	TRANSDUCER X8-2T
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	01/28/2021
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 x8-2t model transducer had an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer could not confirm the articulation issue as described by the customer.However, investigation of the device revealed the connector had corrosion and was chipped, a dented rack actuator, a worn i-tube, and deep bite marks on the window and tip shell.The transducer articulation mechanism was fully functional and met all articulation angle specifications.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.

• Brand Name: X8-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11322785
• Report Number: 3019216-2021-10006
• Device Sequence Number: 17174908
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: 00884838069718
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163120
• 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 X8-2T
• Device Catalogue Number: 989605455171
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/28/2021
• 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: 08/25/2020
• 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