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Model Number ARD568604999 |
Device Problems
Crack (1135); Fracture (1260); 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 Date 03/14/2023 |
Event Type
malfunction
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Event Description
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On 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the 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.Event site name: (b)(6).Device not returned to manufacturer.
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Manufacturer Narrative
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Getinge became aware of an issue with one of our surgical lights ¿ lucea 50.According to initially provided information, the cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Upon further clarification, it has been established that the provided photographic evidence regarded different device and the issue was already reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00212).As it was confirmed by the getinge employee, there was no indication of missing particles on the affected device, which was initially considered.Therefore, it was possible to determine that the issue investigated herein is not safety nor risk related and the scenario described in the record is considered as non-reportable.After reviewing the information provided for the complaints investigated herein we have been able to establish that there is no significant trend with this product and issue type.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.The correction of b5 describe event or problem and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the 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 or problem: on 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the 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.Upon further clarification, it has been established that the provided photographic evidence regarded different device and the issue was already reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00212).Based on additional input from getinge employee, it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: material integrity problem|break|fracture|1260.Mechanical problem|detachment of device or device component||2907.Corrected h6 medical device ¿ problem code: material integrity problem|crack||1135.
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Event Description
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On 14th march 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated and confirmed with photographic evidence, the 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.Upon further clarification, it has been established that the provided photographic evidence regarded different device and the issue was already reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00212).Based on additional input from getinge employee, it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.
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Search Alerts/Recalls
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