One sample was received for evaluation.Visual inspection revealed the device was in used conditions inside a plastic bag; no damage was detected.Functional testing was performed, and the reported issue could not be replicated.The root cause could not be determined.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).
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