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

Model Number Z6MS TRANSDUCER

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: the transducer was returned to siemens for evaluation.During visual inspection, investigation found a dent at the nosepiece area and it was noted that the articulation sleeve was cracked.It is believed that these phenomenons were created from the outside by some physical force.Destructive analysis showed no cuts on the shield braids.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.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type , update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.Investigation: during the device investigation, a dent was found on the nosepiece.A crack on the articulation sleeve was found, which appears to have been cause by an external force.Therefore, the most probable cause is due to customer misuse.It was recommended to the customer to handle the transducer carefully.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.Original files are attached.This emdr contains both the initial submission and fu#2 (fu#1 could not be located).

Event Description

As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that a hole in the articulating sleeve was noted during leakage current test and before the start of the procedure.There was no patient involvement.No additional information was provided.

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• MDR Report Key: 6312911
• MDR Text Key: 270997238
• Report Number: 3009498591-2016-00401
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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