MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY

Model Number PRODUCT VYNTUS BODY

Device Problem Mechanical Problem (1384)

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

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2023 during a complaint search it became evident, that this complaint is a similar complaint to the reportable complaint (b)(4).The reporting decision was updated accordingly.During the remote troubleshooting the most probable sequence of events leading to the breakdown of the device was identified.The us sensor was either not properly screwed in the fpv or loosened over time.The us sensor fell off, was for a moment caught by the cable, bevor finally tumbling to the ground.The customer was trained to properly screw the us sensor in the fpv and the device was repaired on site.The capa investigation identified the following root cause: misuse of the uss as a ¿handle¿ to change the support arm position instead of using the proper handle of the vyntus body support arm or the support arm itself.This misuse loosens the mechanical connection between the uss and the fpv so it becomes insufficient to hold the uss in place.

Event Description

The customer called and complained about the fixation of the us sensor.A falling us sensor caused most probably the breakdown of the device.No patient involvement.

• Brand Name: PRODUCT VYNTUS BODY
• Type of Device: VYNTUS BODY
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg ; GM
• MDR Report Key: 17824876
• MDR Text Key: 324356255
• Report Number: 9615102-2023-00137
• Device Sequence Number: 1
• Product Code: JEH
• UDI-Device Identifier: 04250892904672
• UDI-Public: (01)04250892904672(11)170912
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2023

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 Model Number: PRODUCT VYNTUS BODY
• Device Catalogue Number: VYNB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2017
• 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