MAUDE Adverse Event Report: S7-3T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number TRANSDUCER S7-3T

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2020

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 s7-3t model transducer had an articulation issue during use.There was no injury associated with this event.

Manufacturer Narrative

Evaluation of the transducer confirmed the imaging issue was rotational and not an articulation failure.The transducer failed parallel resistance and image rotation performance tests.Investigation of the device revealed dried fluid ingress and corrosion in the cable, a dent in the cable jacket, and scratches to the beading, window, and tipshell.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.

• Brand Name: S7-3T
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 10984036
• MDR Text Key: 220687296
• Report Number: 3019216-2020-00117
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061439
• UDI-Public: 00884838061439
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRANSDUCER S7-3T
• Device Catalogue Number: 989605406772
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/19/2021
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2020
• 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