Results: the power inlet on the back of the penumbra system aspiration pump max 110 (pump max) was damaged.Conclusions: evaluation of the returned device revealed that the pump max power inlet was loose.The pump max was plugged in and powered on and functioned without an issue.However, the power inlet on the back of the pump max was damaged and, therefore, the pump max was deemed nonfunctional.The reported issues of the power inlet being full of plastic, bent, and the power cord not being able to be plugged in could not be confirmed.Penumbra pump maxs are 100% functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, the technician found that the bracket for the power inlet on the pump max was broken, full of plastic, and was bent; therefore the power cord was unable to be plugged in.The power inlet was cleaned out, and the procedure was continued using the pump max.There was no report of an adverse effect to the patient.
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