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Model Number CCU, ARTHREX SYNERGYUHD4, MATRIX |
Device Problems
Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Melted (1385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2023 |
Event Type
malfunction
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Event Description
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On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3200-0020 ccu had a fault on storx connector where it burnt/melted cord and metal.No case involvement.Additional information has been requested.On 1/10/2023, the sales representative provided the following additional information via phone: the plug into the ccu was burnt on the inside, and also the cable was burnt and the metal was melted where it connected.The staff did not notice any burnt smell or smoke and no one was harmed.This occurred during an unspecified time.
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Manufacturer Narrative
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The complaint is not confirmed.Visual evaluation: the plate capacitor spring was damaged prior to device return.No other issues were observed.No external evidence of burning was observed.Functional evaluation: ccu (b)(6) was subjected to functional testing per (b)(4).No functional issues were observed.The device was rebooted several times and re-evaluated and no functional issues were observed.All video output ports were individually tested and no functional issues were observed.The light engine led temperature was also measured after 1 hour of the led being illuminated and remained under 48° c.The test light guide was inspected and no damage was detected.The other associated material, "the plug into the ccu," was not returned with the ccu and therefore could not be inspected.The reported event of "an ar-3200-0020 ccu had a fault on storx connector where it burnt/melted cord and metal" was not confirmed.
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Search Alerts/Recalls
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