Model Number AB2000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Urinary Retention (2119)
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Event Date 09/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Investigation by manufacturer is currently in-process.
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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 urinary retention, which was addressed by performing cauterization (per manufacturer's instructions for use, urinary retention 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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A review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review 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 therere one (1) nonconformance generated during the manufacturing process of this system.The review indicated that the nonconformance was unrelated to the reported event.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 four (4) similar events that have been reported across all other systems.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.D, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.O urinary retention.A root cause for the reported event could not be determined.Urinary retention are potential risks 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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H.11 corrected data: 1) b5.Describe event or problem - please refer to updated description of event.2) h.6 event problem evalucation codes.The correct health effect - clinical code is "1888 - hemorrhage/bleeding" 3) h.10 additional manufacturer narrative: the aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.D, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.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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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 clot retention, which was addressed by performing 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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Search Alerts/Recalls
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