Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint will be returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Ref: e-complaint-(b)(4).Analysis and findings: the reported event cannot be verified as the affected sample was not available at the time of this investigation.If the affected sample is returned in the future the complaint may be reopened and addressed as needed.Although indeterminable, it may be that the reported event was the result or symptom of a faulty grounding pad, or incompatibility with another device or component that was used in conjunction with the csi ball electrodes.The ball electrode is an outlet for power being supplied through it and does not have ground circuitry, thus, it's not likely that the ball electrode is the root cause for the reported event.A review of the lot dhr did not reveal any abnormality.Correction and/or corrective action: root cause is indeterminable as the affected sample was not available at the time of this investigation.Reason: per bsr-qar-026, this complaint will be monitored for trending in that no injury was reported to end user or patient.Was the complaint confirmed? no.
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