Catalog Number 4126120000 |
Device Problems
Disassembly (1168); Battery Problem (2885)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/14/2014 |
Event Type
malfunction
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Event Description
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It was reported that while aseptic battery housing opened up during a medical procedure and non-sterile battery fell on the sterile surgical site.It was removed by hand using gloves.The housing was being used with system 5 sagittal saw.The procedure was completed without a clinically significant delay; no adverse consequences or medical intervention were reported with this event.
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Event Description
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It was reported that while aseptic battery housing opened up during a medical procedure and non-sterile battery fell on the sterile surgical site.It was removed by hand using gloves.The housing was being used with system 5 sagittal saw.The procedure was completed without a clinically significant delay; no adverse consequences or medical intervention were reported with this event.
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Manufacturer Narrative
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The reported event, housing door opened during use, was duplicated.The technician confirmed that the housing opened during functional testing.The latch was disassembled and debris was found around the latch mechanism.A worn rubber seal and broken internal contact were also found.A degraded o¿ring can be caused by improper sterilization.Device was placed in parts retention.
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Manufacturer Narrative
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The device has been received, but the evaluation has not yet begun.Additional information may be submitted once the quality investigation is complete.
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Search Alerts/Recalls
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