Catalog Number 6541-2-713 |
Device Problems
Contamination (1120); Crack (1135); Degraded (1153); Peeled/Delaminated (1454); 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 06/16/2016 |
Event Type
malfunction
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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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Event Description
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Rubber on handles and impactors are cracked and peeling.Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.
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Manufacturer Narrative
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An event regarding santoprene damage involving a size 4-8 keel punch guide was reported.The event was confirmed.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Visual inspection showed the device handle was discolored and degraded.The 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.
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Event Description
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Rubber on handles and impactors are cracked and peeling.Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.
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Search Alerts/Recalls
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