On (b)(6) 2021 getinge became aware of an issue with volista access surgical light.The paint peeling occurred on fork's keypad, what was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
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Getinge became aware of an issue with volista access surgical light.The paint peeling occurred on fork's keypad, what was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification, since appearance of chipped paint could be considered as technical deficiency, and in this way device contributed to event.The provided information indicates that the device was not being used for patient treatment when the event took place.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.It is also recommended to avoid excessive friction during cleaning or inappropriate cleaning products.We believe that remaining devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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