MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY

Catalog Number	VYNB
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer called and reported that the uss fell from the fpv, caught by and hanging on the cable.After installing the uss again, the vyntus body cabin showed the following boot results "blue/orange blinking led strip" and the error message "communication, device not found.
Additional Manufacturer Narrative
On 8.Sept.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.Remote troubleshooting with the customer was performed.It appeared that the uss interface cable was damaged when uss fell off of the fpv block.The customer replaced the cable and the system worked again as specified.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.

• 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: 17827353
• Report Number: 9615102-2023-00139
• Device Sequence Number: 2342824
• Product Code: JEH
• UDI-Device Identifier: 04250892904672
• UDI-Public: (01)04250892904672(11)20210218
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 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 Catalogue Number: VYNB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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