On (b)(6) 2019, richard wolf medical instruments corporation (rwmic) received report regarding the two components of the piranha system: motor control unit part # 2303.011 - to be reported in mdr 1418479-2019-00031, suction pump part # 2208011 - to be reported in mdr 1418479-2019-00032, it was reported that the pump for the piranha is defective.Photos were provided and showed that the pump presented with "vacuum sensor defective" and "device defective" error codes.The following additional information was provided on june 27, 2019 by the initial reporter: the malfunction occurred during the middle of a procedure.The machine was turned off and back on in an attempt to resolve the issue.Additionally, the tubing, filters, prostate collection canister, as well as the lids on the fluid canisters and fluid canisters, were changed.There were cracks on the fluid collecting canisters noticed, the canisters were submerged in water later to confirm that there were no cracks present.As a result of the malfunction the surgeon had to convert the procedure to a transurethral resection of the prostate (turp) after they had already enucleated the prostate.The prostate tissue floating in the bladder had to be "turp'ed" resulting in an additional hour that the patient was under anesthesia.
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