MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for AQUABEAM ROBOTIC SYSTEM AB2000 manufactured by Procept Biorobotics Corporation.

Event Text Entries

[188341689] A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure, which could be related to the reported event. The system functioned as designed. A review of the device history record (dhr) serial number (b)(4) 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 events was conducted on the aquabeam robotic system, lot number 19c01641, which confirmed that there were no other similar events reported on this system. The aquabeam robotic system's instructions for use (ifu), ifu0101, rev. C, states the following: 4. 3. Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding. 8. 30. Sterile: after the aquabeam handpiece removal, follow the standard clot evacuation procedure to remove clots and tissue with a cystoscopic sheath by using an ellik bladder evacuator or toomey syringe. Use one of the following methods to achieve hemostasis: non-resective bladder neck cautery followed by foley balloon catheter insertion. The system was not returned for investigation of this event. 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.
Patient Sequence No: 1, Text Type: N, H10

[188341690] A male patient underwent an aquablation procedure. Post-aquablation procedure, the patient was taken back to the operating room for debridement and cauterization to address bleeding (per manufacturer's instructions for use, bleeding is a potential risk of the aquablation procedure). Additional information was later received that the patient received a blood transfusion (number of units unknown) and was discharged in good condition two (2) days post-aquablation procedure. No malfunction of the aquabeam system was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3012977056-2020-00012
MDR Report Key9908521
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-12-19
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DORIA ESQUIVEL
Manufacturer Street900 ISLAND DRIVE SUITE 170
Manufacturer CityREDWOOD CITY, CA
Manufacturer CountryUS
Manufacturer Phone2327291
Manufacturer Street900 ISLAND DRIVE SUITE 101
Manufacturer CityREDWOOD CITY, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodePZP
Date Received2020-03-31
Model NumberAB2000
Catalog NumberAB2000
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer Address900 ISLAND DRIVE SUITE 101 REDWOOD CITY, CA US


Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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