MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE, PRODUCT CODE: ITX

Model Number Z6MS

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem Ulceration (2116)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr will be supplemented if additional information is received. Reference complaint # (b)(4).

Event Description

It was reported that an "in patient" underwent a trans-esophageal echocardiography (toe) procedure. During the procedure, the transducer folded over on itself inside the patient's esophagus. The transducer was inserted 10-15 cm without an issue. It was then noted that the image was inverted. Because there was no trouble when inserting the transducer it was further advanced into the stomach where normal manipulation was attempted. It was confirmed via x-ray that the transducer had folded over. The med team took the patient to icu and used a pediatric endoscope under sedation to examine the transducer and remove it - no surgery required. During the endoscope procedure a sub mucosal ulceration was observed, however, no perforation was observed. There was no injury reported. The patient was discharged to the ward two days later. No additional information was provided.

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE, PRODUCT CODE: ITX
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: christine dunn ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4257851617
• MDR Report Key: 8237710
• MDR Text Key: 134493688
• Report Number: 3009498591-2019-00001
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: Z6MS
• Device Catalogue Number: 10436113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse