Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005 getinge usa sales, llc (b)(4).Contact person: (b)(6).Maquet sas became aware of an incident with surgical light volista device.As it was stated by the technician, the main arm started to rust.There was no injury or contamination by falling rust particles reported however we decided to report the issue in abundance of caution.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the issue.The information about the time when the event occurred was not provided, we do not know if the device was not being used for the patient treatment.During the investigation it was found that to date the issue appears not to be a systematic problem, rather a single issue - and that the reported scenario has never lead, to date, to serious injury or worse.The device has been recognized as volista standop with serial numbers ar500008/ar500010 and defective part number ard567910990.Installation date of the device is july, 2016.The manufacturing date is 15th february, 2016.As a fumigation was used by the customer to clean and disinfect the device, the method has led to paint peeling, corrosion and plastic degradation.The correct cleaning protocol was reminded to the customer as fumigation of the device is prohibited.The user manual (standop volista user manual 01761en ed.07 page 63) also included an information that the fumigation method mustn¿t be used to clean and disinfect the device.What is more, every user is informed in user manual (standop volista user manual 01761en ed.07 page 65) to daily check the light-head for chipped paint, impact marks and any other damage.In summary, based on the investigation performed, we have concluded the root cause to be related with user error, who was not following the recommended instruction of device cleaning procedure.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.
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