Model Number SPL-SR |
Device Problem
Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device was inspected at the olympus (b)(4) site.Inspection determined multiple defects on the socket.Two pins were observed to be bent, socket turned 45° to the right and was found broken.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported that the device connector is defective.No patient involvement on this event.No user injury reported.
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Manufacturer Narrative
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This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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