MAUDE Adverse Event Report: X8-2T; TRANSDUCER

Model Number	TRANSDUCER X8-2T
Medical Device Problem Codes	Positioning Failure (1158); 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	10/07/2020
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 x8-2t model transducer had an articulation issue preventing tip motion.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, black box, and articulation tests.Visual inspection noted a hole in the tip shell and inferior beading.Destructive testing identified an insufficient solder joint allowed the steering cable to be separated from the rack actuator 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.
Event or Problem Description
A customer reported an x8-2t model transducer had an articulation issue preventing tip motion.There was no injury associated with this event.

• Brand Name: X8-2T
• Common Device Name: TRANSDUCER
• MDR Report Key: 10684098
• Report Number: 3019216-2020-00105
• Device Sequence Number: 10871954
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: 00884838069718
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Distributor Facility Aware Date: 12/21/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 01/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2020
• 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