MAUDE Adverse Event Report: X8-2T; TRANSDUCER

Model Number TRANSDUCER X8-2T

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2020

Event Type  malfunction  

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 Description

A customer reported an x8-2t model transducer had an articulation issue preventing tip motion.There was no injury associated with this event.

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 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
• Type of Device: TRANSDUCER
• MDR Report Key: 10684098
• MDR Text Key: 211923139
• Report Number: 3019216-2020-00105
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: 00884838069718
• Combination Product (y/n): N
• PMA/PMN Number: K163120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1