(b)(4).Maquet (b)(4) became aware of an incident with a surgical light volista standop device.As stated by technician, the problem with cracked fork and paint chip occurred.There is no patient injury reported however we decided to report the issue in abundance of caution as any particle falling might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.We have no information when the event occurred and if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead to serious injury or worse, to death.The crack appears due to the detachment of the bonded parts and is only located on the outer coating.The cause of the coating damage corresponds to an excessive gap between both mechanical parts revealed before the coating manufacturing process.Maquet (b)(4) launched the capa (b)(4) and the design change request (b)(4) to improve the method for assembling the brackets replacing the bonding method by a welding process.The bracket assembled with the welding process is available since the beginning of 2017.A follow-up medwatch will be submitted when additional information becomes available.
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