Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complete a follow up report will be filed.Ref: e-complaint-(b)(4).Investigation: initiated manufacturer's investigation no sample returned analysis and findings: the reported event cannot be verified due to the absence of the affected device at the time of this investigation.However, if the affected device is returned in the future, and made available for investigative analysis the complaint may be reopened and addressed as needed.This device is oem manufactured for csi which sends it to another outside contractor for sterilization and distributes it from fg warehouse trumbull.All devices are is 100% inspected by the oem before being shipped to csi in trumbull, ct.*correction and/or corrective action: corrective action is not warranted at this time due to the absence of the affected device for proper investigative analysis.Reason: per (b)(4), 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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