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Model Number PAPS3 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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The patient was undergoing a thrombectomy procedure using a penumbra engine canister (canister) and a penumbra engine (engine).During the procedure, the canister would not provide proper suction.The physician tried to troubleshoot the problem by clearing the line; however, the canister still would not provide proper suction.Therefore, the canister was removed.The procedure was completed using a new canister.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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