MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY

Model Number	VYNTUS BODY
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Environmental Particulates (2930)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint search on 20-nov-2024 revealed that this event was unintentionally not categorized as a product complaint.This report is therefore submitted late.The device was not returned for an investigation and further information is requested to further investigate the issue.A previous capa investigation identified the following root cause of this event: misuse of the uss as a ¿handle¿ to change the support arm position instead of using the proper handle of the support arm.This misuse loosens the mechanical connection between the uss and the fpv so it becomes insufficient to hold the uss in place.As a result of the capa, the instructions for use were updated accordingly to ensure that future incidents are avoided.Nevertheless, as new incidents of this type were reported by customers a new capa was raised to prevent further occurrences.This incident is classified with a risk level of medium and is an acceptable patient risk.
Event or Problem Description
On 22-oct-2024 vyaire was informed by a customer, that the uss module was dropped while conducting the test on patient and the uss cable dislodge from the sensor leave only the cable cover on it.The customer reconnected the cable to the uss sensor without turning off the vyntus body.Due to the missing cable cover this resulted in smoke coming out of the fpv module.There was no patient harm reported, further information is requested.

• Brand Name: PRODUCT VYNTUS BODY
• Common Device Name: 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 97204 ; GM 97204
• MDR Report Key: 20746540
• Report Number: 3010838917-2024-00126
• Device Sequence Number: 12856391
• Product Code: BZC
• UDI-Device Identifier: 04250892905693
• UDI-Public: (01)04250892905693
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K190853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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
• Operator of Device: Health Professional
• Device Model Number: VYNTUS BODY
• Device Catalogue Number: VYNB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown