Model Number 52969 |
Device Problem
Temperature Problem (3022)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has been returned by the customer and evaluated.Once the investigation process is completed a follow-up report will be filed.(b)(4).
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Event Description
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Review of service and repair logs reference repair order log (b)(4).Per repair authorization form: "intermittent heat problem when cutting." "not hot at times during the procedure." (b)(4).
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Manufacturer Narrative
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Reference e-complaint (b)(4).Please find attached the leep 1000 final mdr submission package, regarding all initial mdr's, and retro review initial mdr's filed for reports of intermittent function during use.The documents included in this package are as follows: · leep system investigation summary · leep 1000 tech bulletin cover letter · tech service bulletin 12151 · project #(b)(4)- leep system 1000 root cause.This concludes coopersurgical' s root cause investigation.Coopersurgical, inc.Will continue to monitor the complaint condition for tending and safety.
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Event Description
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Review of service and repair logs reference repair order log (b)(4)- per repair authorization form "intermittent heat problem when cutting." "not hot at times during the procedure." ref e-complaint (b)(4).
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Search Alerts/Recalls
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