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 Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2020

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 x7-2t model transducer experienced an articulation issue during use.There was no injury associated with this event.

Manufacturer Narrative

A thorough technical investigation of the suspect transducer was to be performed; however, the customer decided to retain the device.Both the system and the transducer remain at the customer site with no return anticipated; therefore, no further failure analysis can be performed.If the issue recurs, another complaint record will be generated to further investigate the problem.Customer did not replace device.

• Brand Name: X7-2T
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 10971221
• MDR Text Key: 220910523
• Report Number: 3019216-2020-00116
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838023987
• UDI-Public: 00884838023987
• Combination Product (y/n): N
• PMA/PMN Number: K030455
• 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: 12/08/2020
• 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: 989605361911
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/14/2021
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2017
• 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