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

Model Number TRANSDUCER X7-2

Device Problem Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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 x7-2t model transducer had an articulation issue during use.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 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
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11322810
• MDR Text Key: 231789473
• Report Number: 3019216-2021-10007
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: 00884838061668
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• 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: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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