As reported, hydro-surg had fluid leak and running hot.The subject product was returned for evaluation.Visual examination of the returned device confirms a fluid leak presented into the device housing.This resulted in minor corrosion inside of the hydro-surg battery case.The fluid leak presented and passed the lip seal barrier.Rtv is identified on the motor mount allowing fluid to pass through the motor mount and down the sides of the motor to the pc board and battery compartment.Based on the sample evaluation and the condition of the device the root cause determined to be manufacturing related.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october,2022.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3: sample evaluated.
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