On 16th june, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was broken and label was torn.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
|
Getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was broken and label was torn.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on information provided by getinge technician, the customer received quote for the repair and the status is currently pending his approval.Based on the information collected, it was established that when the event occurred, surgical lights did not meet their specification, since cracks in covers, resulting in missing plastic particles and torn label could be considered as technical deficiency, and in this way device contributed to event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at moderate ratio for the broken covers and very low ratio for the torn labels.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by subject matter expert at the manufacturing site and according to pictures provided, plastic top covers are deteriorated in corners and a broken parts are missing.The damages were probably caused by a collision.A new covers available as spare parts in the kit must be installed in order to replace damaged covers and to avoid any incident.To prevent any safety issue user manual for lucea 50/100 (ifu 01741 en 10, pages 26-27) mentions to check the light heads for chipped paint, impact marks and any other damage, during the daily check.The other issue concerning transparent sticker (label) which was torn and peeling off, as stated by the subject matter expert, it is not a label provided by maquet sas.Therefore, there could be no investigation performed to establish root cause.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
|