On 23rd june, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was cracked.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.
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Getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was cracked and particles were missing.There was no injury reported, however, we decided to report the issue in an abundance of caution as any particles falling off into a sterile field or during a procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since the crack of covers, leading to missing plastic particles could be considered a technical deficiency, and in this way the device contributed to the event.The 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 issue we were able to establish that the received incidents are occurring at a moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to the analysis performed by the subject matter expert regarding the cracks on transparent cover, the incident is due to inappropriate use.A shock with another device is the most probable root cause of this incident.If the described failure occurs, the user can visually detect it during the daily checks performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.To prevent any incident the lucea50-100 user manual (ifu 01741 en 10, pages 26-27) mentions: ¿check the light heads for chipped paint, impact marks and any other damages¿ during the daily inspections.As stated by the subject matter expert at the manufacturer¿s site, according to the picture provided, the plastic top cover is deteriorated in the corner and a broken part is missing.The damages were probably caused by a collision.The cover involved was not returned for evaluation.A new cover available as spare parts in the kit ard368609996 must be installed in order to replace the cover damaged and to avoid any incident.To prevent any safety issue the instruction for use 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.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s 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.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was cracked.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.Corrected b5 describe event or problem: on (b)(6) 2022, getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was cracked and particles were missing.There was no injury reported, however, we decided to report the issue in an abundance of caution as any particles falling off into a sterile field or during a procedure may cause contamination.
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On (b)(6) 2022, getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was cracked and particles were missing.There was no injury reported, however, we decided to report the issue in an abundance of caution as any particles falling off into a sterile field or during a procedure may cause contamination.
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