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

Model Number Z6MS TRANSDUCER

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to siemens for investigation.During visual inspection, it was discovered that the guide tube monocoil was detached from the lug in the articulation section of the transducer.The dislocation of the monorail had caused a kink when the guide tube was stressed perpendicular to the force applied, which caused the reported mechanical defect at the tip.There was also a bite mark noted at the distal tip.Based on the initial report and the evaluation findings, the possible root cause of the issue was due to tight packing of the gastro flex circuit which restricted the motion inside the cable assembly.This issue in the cable assembly is addressed by (b)(4), where in the corrective action, the cable bundle diameter was decreased.Engineers stated that the flex/cable packaging could stress the part during insertion which can cause kinking and that the new flex/cable packaging (post-capa) has smaller outer diameter and will help prevent this type of failure.The cable assembly design changed with smaller cable bundle outer diameter since jul.2017.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.(b)(4).

Event Description

It was reported that the tip of the transducer was found to be soft; however, it had not affected the image quality nor compromised the safety of the patient.The transducer was used until it was replaced.Accordingly, the user thinks that the issue could have been there since the beginning but was now noticed.There was no report of patient adverse event.No additional information was provided.

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4252709862
• MDR Report Key: 7646293
• MDR Text Key: 112740095
• Report Number: 3009498591-2018-00031
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z6MS TRANSDUCER
• Device Catalogue Number: 10436113
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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