MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABLATION; FLUID JET REMOVAL SYSTEM

Patient Problems Unspecified Infection (1930); Laceration(s) (1946)

Event Date 08/28/2023

Event Type  Injury  

Event Description

Aquablation therapy surgery tore rectum resulting in severe infection and subsequent colostomy surgery.Patient was in icu and hospital for 28 days.Patient may not survive.

• Brand Name: AQUABLATION
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION
• MDR Report Key: 17855696
• MDR Text Key: 324832724
• Report Number: MW5146353
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2023
• Patient Sequence Number: 1
• Treatment: SYNTHROID.
• Patient Outcome(s): Disability; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White