Catalog Number 6541-4-811 |
Device Problems
Melted (1385); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/21/2015 |
Event Type
malfunction
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Event Description
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Staff made rep aware that devices "potentially" had adhesive melt under rubber handle.Noticed oil in bottom of tray when it came out of autoclave.No patient outcome was compromised because pan wasn't in o.R.Room and additional trays were available and used.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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The returned impactor tip was unremarkable.The plastic impaction pad is marked and scratched consistent with normal use.The damaged device was discovered during inspection; there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Staff made rep aware that devices "potentially" had adhesive melt under rubber handle.Noticed oil in bottom of tray when it came out of autoclave.No patient outcome was compromised because pan wasn't in operating room and additional trays were available and used.
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Search Alerts/Recalls
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