Investigation x-inspect returned samples *analysis and findings complaint: (b)(4).Distribution history: this complaint unit was manufactured at csi on 12/15/2004 under wo #31240 and shipped on 1/8/2005.Manufacturing record review: a review of the device history record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed.Should the device history record be located going forward this complaint will be amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on repair log 96684.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the foot pedal is used to activate the device.If not functioning the power to the unit will not flow.The foot pedal has been known to fail due to a few reasons.The most common is the diaphragm in the switch 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 in the switch to turn the power on.The foot pedal creates the air displacement to the pneumatic switch.Given the appearance of a bad diaphragm it appears to have been exposed to excessive stimuli.Latex is 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.The root cause for this complaint condition is component related to the diaphragm.*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.The ifu was also updated to add a safety check via (b)(4), p/n (b)(6).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.Correction activity in 2016.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
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