Model Number APOLLO RF 90° MULTIPORT |
Device Problems
Break (1069); Loose or Intermittent Connection (1371); Melted (1385)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/28/2022 |
Event Type
malfunction
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Event Description
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It was reported on (b)(6) 2022 by a sales representative via sems that an ar-9811 apollo probe tip melted and was coming loose.Case involvement, device broke during use.
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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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Review of this complaint confirmed the event summary code selection and an investigation including a product history review was performed as required.The complaint device was not returned for investigation, however, picture(s) of the complaint device were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was not able to be determined.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per wi-000100100.
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Search Alerts/Recalls
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