Model Number 52969 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2016 |
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 was returned by the customer and evaluated.Once the investigation is completed a follow-up report will be filed.(b)(4).
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Event Description
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Review of repair order log (b)(4).Per repair authorization form: "the machine did nothing when placed on cut and or blend.We were only able to perform leep with the loop on coag.We turned the machine off and back on, used a new pencil, checked all connections and were still unable to use the cut or blend function." (b)(4).
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Manufacturer Narrative
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(b)(4).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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(b)(4).Per repair authorization form: "the machine did nothing when placed on cut and or blend.We were only able to perform leep with the loop on coag.We turned the machine off and back on, used a new pencil, checked all connections and were still unable to use the cut or blend function." (b)(4).
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Search Alerts/Recalls
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