Model Number 52969 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/19/2016 |
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 to the customer and evaluated.Once the investigation is completed a follow-up will be filed.Reference complaint: (b)(4).
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Event Description
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Review of service and repair log # (b)(4).Follow up questionnaire: "foot pedal failed to work during the procedure.Patient was taken to the or for suture placement." reference complaint: (b)(4).
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Manufacturer Narrative
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(b)(4).A review of the dhr is not available but not expected to provide useful information for this complaint.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.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 dfu was also updated to add a safety check.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.This complaint will be entered into the coopersurgical continuous improvement plan (cip).
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Event Description
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Review of service and repair log # (b)(4).Follow up questionnaire: "foot pedal failed to work during the procedure.Patient was taken to the o.R.For suture placement." (b)(4).
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Search Alerts/Recalls
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