MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-03 for AQUABEAM ROBOTIC SYSTEM AB2000 manufactured by Procept Biorobotics Corporation.
[176390060]
A review of the aquabeam robotics system's log file confirmed no malfunctions related to the reported event. The review of the log file indicated that the system functioned as designed. A review of the device history record (dhr) for the aquabeam robotics system, lot number 19c00119, was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event. The review indicated that the system met all required specifications when released for distribution. A review for similar complaints on the aquabeam robotics system, lot number 19c00119, confirmed that there have been no other similar events 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. The system was not returned for investigation of this complaint. 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. Additionally, information received from the treating physician confirmed that chemotherapy drugs being administered for leukemia treatment to the patient may have been a contributing factor on this event.
Patient Sequence No: 1, Text Type: N, H10
[176390061]
A male patient receiving medical treatment for leukemia underwent an aquablation procedure. Per standard post-operative procedure, the patient was catheterized with a foley balloon catheter and taken into the post-anesthesia care unit (pacu). In the pacu, the patient's catheter turned red (per manufacturer's instructions for use, bleeding is a potential risk post-aquablation procedure) and hemoglobin levels decreased from 13 g/dl (pre-operative procedure) to 8 g/dl (post-operative in pacu). The patient was taken back to the operating room for a cystoscopic procedure and fulguration of the prostate, where hemoglobin levels further decreased to 6. 6 g/dl; therefore, two (2) units of packed red blood cells (prbcs) and one (1) unit of fresh-frozen plasma (ffp) were administered. The physician proceeded to perform clot evacuation and cauterization around the bladder neck and prostatic fossa. No overt arterial bleeding observed but oozing noted throughout the prostatic fossa despite cauterization efforts. The treating physician ordered a coagulation test, which showed elevated international normalized ratio (inr) of 1. 4 and prothrombin time (pt) of 16 seconds. The physician assessed that chemotherapy drug being administered to the patient for leukemia treatment could have effects on coagulation factors. After bleeding was controlled with cauterization, a new foley balloon catheter was inserted in the prostatic fossa and inflated to 40cc; the catheter color was dark pink. The patient was reported to be in good condition. No further clinical sequela was reported with the patient. No malfunction of the aquabeam robotic system was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012977056-2019-00068 |
| MDR Report Key | 9549321 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-06 |
| Device Manufacturer Date | 2019-01-31 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DORIA ESQUIVEL |
| Manufacturer Street | 900 ISLAND DRIVE SUITE 170 |
| Manufacturer City | REDWOOD CITY CA 940651494 |
| Manufacturer Country | US |
| Manufacturer Postal | 940651494 |
| Manufacturer Phone | 6502327291 |
| Manufacturer G1 | PROCEPT BIOROBOTICS CORPORATION |
| Manufacturer Street | 900 ISLAND DRIVE SUITE 101 |
| Manufacturer City | REDWOOD CITY CA 940651494 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 940651494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUABEAM ROBOTIC SYSTEM |
| Generic Name | FLUID JET REMOVAL SYSTEM |
| Product Code | PZP |
| Date Received | 2020-01-03 |
| Catalog Number | AB2000 |
| Lot Number | 19C00119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCEPT BIOROBOTICS CORPORATION |
| Manufacturer Address | 900 ISLAND DRIVE SUITE 101 REDWOOD CITY CA 940651494 US 940651494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-03 |