Model Number 017416 |
Device Problems
Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Physical Property Issue (3008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Empowercta+ articulating and j-arm broke away and fell.The operator hold the system when it fell.There was no patient nor operator injury.However there may be the potential of injury, if the issue was to reoccur.The investigation is ongoing.(b)(4).
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Event Description
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On (b)(6) 2018, a healthcare professional reported to bracco injeneering a device malfunction with the use of the articulating arm of empowercta+.The report was forwarded to bracco drug safety on 23-feb-2018.On (b)(6) 2018, the empowercta+ articulating and j-arm broke away and fell.The operator held the system when it fell.There was no patient nor operator injury.However there may be the potential of injury, if the issue was to reoccur.A quality investigation is ongoing.
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Manufacturer Narrative
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Empowercta+ articulating and j-arm broke away and fell.The operator hold the system when it fell.There was no patient nor operator injury.However there may be the potential of injury, if the issue was to reoccur.The investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the subassembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The case is then considered closed.
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Event Description
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On (b)(6) 2018, a healthcare professional reported to (b)(4) injeneering a device malfunction with the use of the articulating arm of empowercta+.The report was forwarded to (b)(4) drug safety on 23-feb-2018.On (b)(6) 2018, the empowercta+ articulating and j-arm broke away and fell.The operator held the system when it fell.There was no patient nor operator injury.However there may be the potential of injury, if the issue was to reoccur.The investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the sub-assembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The case is then considered closed.Most recent follow-up information incorporated above includes: on 25-apr-2018: quality investigation report added to the case.12-jun-2018: case corrected after internal review by (b)(4).(b)(4) removed as importer.Importer number removed from report number page.The investigation report attachment was removed from file attachments page.Corresponding worldwide case id provided.A new form fda 3500a case was generated.(b)(4).
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Manufacturer Narrative
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Empowercta+ articulating and j-arm broke away and fell.The operator hold the system when it fell.There was no patient nor operator injury.However there may be the potential of injury, if the issue was to reoccur.The investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the sub-assembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The case is then considered closed.Exemption number: e2018011.Bracco diagnostics inc.(importer) is submitting this report on behalf of bracco injeneering s.A.(manufacturer).- attachment: [2018us02609_binj quality investigation report.Pdf].
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Event Description
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On 26-jan-2018, a healthcare professional reported to bracco injeneering a device malfunction with the use of the articulating arm of empowercta+.The report was forwarded to bracco drug safety on 23-feb-2018.On 26-jan-2018, the empowercta+ articulating and j-arm broke away and fell.The operator held the system when it fell.There was no patient nor operator injury.However there may be the potential of injury, if the issue was to reoccur.The investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the sub-assembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The case is then considered closed.Most recent follow-up information incorporated above includes: on 25-apr-2018: quality investigation report added to the case.
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Search Alerts/Recalls
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