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Model Number 52969 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2018 |
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 complete, a follow up report will be filed.(b)(4).
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Event Description
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Service and repair log 88381 review: when pressing on pedal to cauterize it would work for about 6 seconds then would stop working.Changed the 1- adapter plug, 2- adapter for patient, 3- leep ball electrode, 4- foot controlled handle with standard blade electrosurgical handle.Would reposition the adapter plug - foot controlled handle and it would work approximately another 4-6 seconds then stop again.
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Event Description
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Service and reapir log 88381 review: when pressing on pedal to cauterize it would work for about 6 seconds then would stop working.Changed the 1- adapter plug, 2- adapter for patient, 3- leep ball electrode, 4- foot controlled handle with standard blade electrosurgical handle.Would reposition the adapter plug - foot controlled handle and it would work approximately another 4-6 seconds then stop again.
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Manufacturer Narrative
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Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.Reference (b)(4).Update 5/16/2018.Investigation: inspect returned samples: analysis and findings; a review of the 2 yr complaint history reveals no similar issues.This unit was manufactured in 2010.Service and repair confirmed the foot pedal was not properly functioning.The foot pedal is used to activate the device.If not functioning the power to the unit will not flow and it will not cut.The unit was obtained from alsa, an italian manufacturer, and integrated with csi products with minor adjustments that does not involve modifications to the internal board.The foot pedal has been known to fail due to a few reasons.The most common is the diaphragm which acts as the mechanism to make contact (for electrical current) to supply power to the unit.Air displacement pushes on a piston via the diaphragm into a switch to turn the power on.The foot pedal creates the air displacement to the pneumatic switch mechanism located in the housing of the unit.The diaphragm breaks down just enough to lose its seal and cannot function properly.The diaphragm material has been described as a rubber, possibly a latex.Given the appearance of a bad diaphragm it appears to have been exposed to excessive stimuli.Materials like latex are flexible hence the use in this application but its elastic properties can alter over time as well.In this condition the sealing properties are impacted and it will not function as intended.The root cause for this complaint condition is component related to the diaphragm.Corrective action: correction and/or corrective action; the unit was repaired and returned to the customer.Sustaining engineering has successfully tested a replacement material made of silicone for use in assembly and repairs going forward, eng-test-10341-r.The dfu 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.Corrective action level 3.None reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? yes.
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Search Alerts/Recalls
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