Catalog Number ARD568811962 |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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We are aware that this is past the 30 day deadline for reporting.We have reminded the complaint handler to review fda reporting guidelines in order to prevent this from happening again.The issue is being investigated by manufacturing site.(b)(4).
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Event Description
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On (b)(4) 2017 maquet (b)(4) became aware of an issue with volista surgical light.As it was stated, the crack on the paint structure was found on the fork of the device.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 might be a source of contamination.(b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer reference number (b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
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Event Description
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Manufacturer reference number (b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer reference number (b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer reference number: (b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer reference number (b)(4),.
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer reference number (b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer reference number (b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
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Event Description
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Manufacturer reference number (b)(4).
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Manufacturer Narrative
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Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas (b)(4).Contact person: (b)(6).The issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer reference number (b)(4).
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Event Description
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Manufacturer reference number 2017-55320.
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Manufacturer Narrative
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Getinge became aware of a customer¿s problem with the volista device.As it was stated, on the preventive maintenance performed by the technician, there were cracks in the paint observed.There was no indication of any injury, however it was decided to report this issue based on the potential and in abundance of caution, as any particle falling from the device into the sterile field might be a source of contamination.When reviewing similar reportable events registered for volista surgical light we were able to find several similar issues compared to the problem investigated herein.In none of the complaints a serious injury or death occurred.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.It was established that the cracks were located only on the outer coating and there was no impact to the internal structure of the fork assembly.The breaks on the coating correspond to the excessive gap between two mechanical parts under the outer material.We have no information regarding the exact time when the defect first appeared or if it was being used for patient treatment in the time when the event occurred.A corrective/preventive action investigation into the issue has revealed that the issue may be the result of several factors, summarized as issues with the previous understanding of post-gluing aspects.A design change improved the assembling methods from glue-bonding to welding of the parts in production, since beginning of 2017.In addition, the device was included in the scope of field action msa-2019-001-iu (registered by fda as z-1852-2019, z-1853-2019, z-1854-2019, z-1855-2019, z-1856-2019, z-1857-2019, z-1858-2019, z-1859-2019, z-1860-2019, z-1861-2019, z-1862-2019, z-1863-2019, z-1864-2019) and it was decided that the defective part will be replaced, therefore getinge does not propose any other action at this time.
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Search Alerts/Recalls
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