A male patient with clinical history of being on coumadin anticoagulant medication for a cardiac pacemaker underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that the patient was taken back to the operating room (or) due to bleeding, which caused hemoglobin (hgb) levels to decrease to 6 g/dl (per the manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).Cauterization was performed to control the bleeding.The patient received a blood transfusion as well, number of units unknown.The patient was taken off anticoagulant treatment six (6) days prior to the aquablation procedure (per manufacturer's instructions for use, do not use the system if unable to stop anticoagulants or antiplatelet agents perioperatively).There were no reported adverse health consequences with the patient because of this event.No malfunction of the aquabeam robotic system was reported.
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The aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for serial number (b)(6) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed that there was one other similar event reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.C, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.Under 3.Contraindications the ifu states: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.In addition, do not use the system in the following: unable to safely stop anticoagulants or antiplatelet agents perioperatively.A root cause for the reported event could not be determined.Bleeding is a potential risk of the aquablation procedure.Per the ifu, patients must be able to safely stop anticoagulant agents before surgery.Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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