PRODUCT VYNTUS BODY

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. A FIELD SERVICE ENGINEER WENT ON SITE AND CHECKED AND REPAIRED THE SYSTEM USING THE FOLLOWING SPARE PARTS: 1 X V-707377, USS MODULE WITH ADAPTER, 1 X V-707389, FPV BLOCK, 1 X V-707392 ASSY HOUSING CLAMP OF FPV, AFTER REPAIR THE DEVICE HAS BEEN CALIBRATED, TESTED, AND WORKS 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.

Description of Event or Problem

THE CUSTOMER CALLED AND REPORTED THAT THE ULTRASOUND SENSOR FELL DOWN CAUSING A DEFECTIVE ULTRASOUND SENSOR AND FPV. NO PATIENT OR USER WAS HIT BY THE FALLING PART.