A customer reported that three healthcare workers (hcws) are stating the design of the evotech¿ is causing them to have back pain.The symptoms occur with the loading and unloading of their scopes.This report is for healthcare worker (b)(6).She reports having severe pain in the mid to lower back.She is (b)(6) and states the evotech¿ sits above her waist.Consequently, she must stand on her tip toes to load scopes and make the scope connections.She is currently wearing a back brace.The hospital¿s occupational staff is working with her for ergonomic solutions.(b)(4) are related complaints from the same facility.This is three of three 3500a reports being submitted.Please reference manufacturer report numbers: 2084725-2015-00111, 2084725-2015-00112 and 2084725-2015-00113.
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Manufacturer date: 01/09/2015.Evaluation: ¿ method: actual device not evaluated.¿ results: no results available since no evaluation performed.Asp investigation summary: the investigation included a review of the device history record (dhr), service history, trending of the product malfunction code, failure mode effects analysis (fmea), and system risk analysis (sra).¿ the dhr (device history record) was reviewed and indicated the unit met specification at the time of its release.¿ the service history for this unit for the past 6 months (11/02/2014 ¿ 05/1/2015) did not reveal a significant trend.¿ the complaint trending for problem code ¿human reaction¿ over the past 12 months (june 2014 ¿ may 2015) did not reveal a significant trend.¿ the fmea (failure mode effects analysis) indicates the rpn for this issue is within limits.¿ the sra (system risk analysis) shows the risk for "exposure to mechanical or physical force" to be low.The cause of the injury can not be verified.The unit meets functionality.Further investigation shows a heavy workload of processing scopes at this facility as well as a history of pre-existing back problems.Therefore, no assignable cause can be determined.The issue appears to be isolated to this facility.However, this issue will continue to be monitored.
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