Model Number AB2000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 08/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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Investigation by manufacturer is currently inprocess.
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Event Description
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A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-procedure the patient was taken back to the operating room due to bleeding, which was addressed by clot evacuation and cauterization (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).No adverse health consequences were reported with the patient due to this event.No malfunction of the aquabeam robotic system was reported.
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Manufacturer Narrative
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H.10 additional narrative/data: please disregard the previously submitted follow-up 1 on 12-oct-2020.The information was for a different event.This event is currently under investigation.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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Manufacturer Narrative
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H.10 additional narrative/data: 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 19c01041 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 19c01041, which confirmed that there was one similar event reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.A root cause for the reported event could not be determined.Bleeding is a potential risk of the aquablation procedure.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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Manufacturer Narrative
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The aquabeam robotic system's log file was reviewed and confirmed no malfunctions occurred 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 were no other similar events reported on this system.There are six (6) similar events that have been reported across all systems.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.B, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists bleeding is a potential risk of the aquablation procedure.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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Search Alerts/Recalls
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