This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).A product sample was received for evaluation.Visual inspection showed tamper seal was intact.Found high pressure, no disposable and power lost while pump was on messages in the event history log.During functional check, the reported complaint was duplicated.Cassette lock worn, case and lens damage issue found during investigation.Found front housing was damaged.Root cause was found to be the worn cassette lock, that was caused by the customer.The latch lock assembly, rear/front housing assembly and lens were replaced.
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