Model Number 52969 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Blood Loss (2597)
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Event Date 05/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical inc.Is currently investigating the reported condition.Once the investigation is completed a follow-up report will be filed.(b)(4).
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Event Description
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Per (b)(4),problem description - " verify function, procedure took too long".Per repair authorization- customer stated description of problem as " verify unit is fully functional".Additional details stated" the procedure was prolonged and caused considerably more bleeding than normal would".(b)(4).
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Event Description
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Per repair log 92069: problem description - " verify function, procedure took too long".Per repair authorization- customer stated description of problem as " verify unit is fully functional".Additional details stated" the procedure was prolonged and caused considerably more bleeding than normal would".Ref: (b)(4).
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Manufacturer Narrative
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Ref (b)(4).Investigation: x-inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals similar issues.This unit was manufactured in 2010 under wo #93823.The complaint was not confirmed by service & repair.The unit was found to function to specifications free of any functional issues.Upon review of the unit it was also noted to have the original diaphragm and updated accordingly.Previous issues with the diaphragm requires all units noted to have an original diaphragm will be updated whether they are faulty or not.The issue was due to a latex material degrading over time.A new material, silicone, was selected to replace it as it is not prone to losing its sealing function as did the latex version.A seal is needed for the pneumatic switch to turn on the power.A root cause for this complaint condition is not available.The root cause for this complaint condition could potentially be outside of the generator itself or end user related.Correction and/or corrective action: coopersurgical service and repair team replaced the diaphragm on the unit and returned it to the customer.Sustaining engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.Was the complaint confirmed? yes.
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Search Alerts/Recalls
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