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Model Number ARD568604998 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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On (b)(6) 2022, getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was cracked with missing particles.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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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.
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Manufacturer Narrative
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The correction of b5 describe event and problem and h4 manufacture date deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 21st june 2022, getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was cracked with missing particles.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 and problem: on 25th may 2022, getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was cracked with missing particles.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.Previous h4 manufacture date: 2021-04-09.Corrected h4 manufacture date: 2021-04-12.According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.
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Event Description
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On 25th may 2022, getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was cracked with missing particles.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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Event Description
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Manufacturer's reference number (b)(4).
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Manufacturer Narrative
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Getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, the cover was cracked with missing particles.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.According to the information provided by the service technician, the device has been repaired by replacement of faulty parts - l50 - s/a upper cover with fork v3, s/a lower cover with dimmer - l50 and set transparent plastic cover - l50.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since a cracked cover leading to missing particles could be considered as 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 issues 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.The issue has been analyzed by the subject matter expert and concluded that according to the picture provided, 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 must be installed in order to replace the cover damaged 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.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.
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Search Alerts/Recalls
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