SIUI Apogee 2300Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 06938396423001), received between Aug 4, 2021 and May 21, 2026 — classified as 2 deaths, 67 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, DURING AQUABLATION THERAPY, A SMALL LACERATION ON THE OUTSIDE OF THE PATIENT'S RECTUM WAS INADVERTENTLY MADE BY THE RESIDENT DURING TRUS INSERTION. THE RESIDENT HAD DIFFICULTY LOCATING THE PATIENT'S RECTUM, AND THE TREATING SURGEON HAD TO STEP IN. THE TREATING SURGEON WAS MADE AWARE OF THE PRESENCE OF BLOOD, AND A SMALL LACERATION WAS OBSERVED ON THE OUTSIDE OF THE PATIENT'S RECTUM. THE LACERATION WAS CLOSED WITH STITCHES AFTER COMPLETION OF AQUABLATION THERAPY, AND THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 25247694 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT EXPERIENCED RECTAL PERFORATION. DURING FOCAL BLADDER NECK CAUTERY (FBNC), THE TREATING SURGEON ADVANCED THE RESECTION BEYOND THE INTENDED TREATMENT AREA INTO THE MID-PROSTATE. THE POSITIONING AND ANGULATION OF THE TRUS PROBE MAY HAVE CONTRIBUTED TO THIS EVENT. A SMALL RECTAL TEAR WAS IDENTIFIED DURING THE PROCEDURE, AND THE TRUS PROBE WAS VISUALIZED ON CYSTOSCOPY. THE SURGEON NOTED THAT THE PATIENT'S ANATOMY WAS INHERENTLY WEAK AND HAD THIN PROSTATIC TISSUE IN THE MID-PROSTATE REGION, WHICH MAY HAVE INCREASED THE RISK OF THIS OCCURRENCE. NO ADDITIONAL SURGERIES OR INTERVENTIONS WERE REQUIRED FOLLOWING THE AQUABLATION PROCEDURE. THE DECISION WAS MADE TO MANAGE THE PERFORATION CONSERVATIVELY, WITH PROLONGED CATHETERIZATION AND AN EXTENDED INPATIENT STAY FOR MONITORING ON THE WARD. THE PATIENT IS REPORTED TO BE DOING WELL. THE SURGEON DOES NOT ATTRIBUTE THE RECTAL PERFORATION TO THE AQUABLATION THERAPY OR DEVICE ITSELF. NO DEVICE MALFUNCTION WAS REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 24852492 ↗
• InjuryApr 4, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, BLOOD WAS OBSERVED ON THE TIP OF THE TRUS PROBE UPON REMOVAL. IT WAS REPORTED THAT THE TREATING SURGEON INSERTED THE TRUS PROBE SLIGHTLY BELOW THE RECTUM, CAUSING A CUT IN THE PATIENT'S RECTUM. A STITCH WAS PLACED, AND THE PATIENT WAS ADMITTED OVERNIGHT, DISCHARGED THE NEXT DAY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Laceration(s)

  MAUDE report 24784757 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT THE PATIENT HAD A RECTAL PERFORATION. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY AND RECEIVED A COLOSTOMY. THE PATIENT IS REPORTED TO BE DOING FINE. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 24142542 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT POST-AQUABLATION THERAPY, THE PATIENT HAD A RECTAL PERFORATION. THE PATIENT WAS THEN TRANSFERRED TO A DIFFERENT FACILITY AND STAYED IN THE INTENSIVE CARE UNIT (ICU). CURRENTLY, THE PATIENT IS IN THE GENERAL SURGERY WARD TO SEE IF THE PERFORATION HEALS ITSELF OR IF SURGICAL REPAIR IS NEEDED. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 24142532 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT WENT SEPTIC. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR SEPSIS. THE PATIENT RECEIVED AN ABDOMINAL CT (COMPUTED TOMOGRAPHY) SCAN DUE TO THE INFECTION, AND A RECTAL INJURY WAS DETECTED. THE PATIENT THEN UNDERWENT SURGERY, AND AN ARTIFICIAL COLOSTOMY WAS APPLIED. THE PATIENT IS REPORTED TO BE DOING FINE. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Bowel Perforation; Sepsis

  MAUDE report 24142508 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT POST-AQUABLATION THERAPY, THE PATIENT PRESENTED WITH A FEVER IN POST-OP CARE AND WAS EXPERIENCING TACHYCARDIA. IT WAS DISCOVERED THAT THE PATIENT HAD AIR IN HIS ABDOMEN, AND THE PATIENT WAS THEN SENT FOR A COMPUTED TOMOGRAPHY (CT) IMAGING, REVEALING A RECTAL PERFORATION. ON (B)(6) 2025, A BOWEL DIVERSION PROCEDURE WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. IT WAS REPORTED THAT NO ISSUES WERE EXPERIENCED DURING THE AQUABLATION THERAPY. STANDARD PROTOCOLS WERE FOLLOWED, AND ALL RECTAL INJURY PREVENTION PRECAUTIONS (PATIENT IN LITHOTOMY POSITION, BUTTOCKS 2 INCHES OFF THE END OF THE BED, DIGITAL RECTAL EXAM, 60CCS OF LUBRICANT DISPENSED IN THE RECTUM, 30CCS OF LUBRICANT PLACED ON TH RECTAL ULTRASOUND) WERE PERFORMED. FOLLOWING THE AQUABLATION THERAPY, THE TRUS PROBE WAS INSPECTED, AND NO BLOOD WAS VISUALIZED. FOLLOWING THE FOCAL BLADDER NECK CAUTERY PROTOCOLS, THE PATIENT'S RECTUM WAS INSPECTED BY THE PHYSICIAN FOR ANY INJURY. NO INJURY WAS FOUND UPON INSPECTION. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPL

  Patient problems: Perforation

  MAUDE report 24142489 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT THE PATIENT SUSTAINED A RECTAL PERFORATION DURING HEMOSTASIS. IT WAS NOTED THAT THE ECBP-1 TRUS PROBE REMAINED IN PLACE DURING HEMOSTASIS AND THE TREATING SURGEON RE-POSITIONED THE ECBP-1 TRUS PROBE APPROXIMATELY THREE (3) TIMES TO GIVE MORE SPACE FOR THE RESECTOSCOPE. DURING LOOP RESECTION AT THE POSTERIOR MID-FOSSA, THE TIP OF THE ECBP-1 TRUS PROBE WAS OBSERVED TO BE PROTRUDING THROUGH THE RECTAL WALL, INDICATING A RECTAL INJURY. EVALUATION FROM A DIFFERENT PHYSICIAN REPORTED THERE WAS A ~1CM OPENING. THE TREATING SURGEON CONFIRMED THAT THE PATIENT RECEIVED A ROBOTIC REPAIR THE SAME DAY AND WAS DISCHARGED THE FOLLOWING DAY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 24142439 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE OF A RECTAL MUCOSAL TEAR WITH THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ITS ASSOCIATED ECBP-1 TRUS PROBE. THE TREATING SURGEON REPORTED THAT BLEEDING WAS NOTED AFTER ECBP-1 TRUS PROBE INSERTION. THE TREATING SURGEON DID A RECTAL EXAM POST ECBP-1 TRUS PROBE REMOVAL AND NOTED SMALL EXTERNAL MUCOSAL TEAR NEAR ANUS. THE TREATING SURGEON NOTED NO ISSUES WHEN DOING AN INTERNAL RECTAL FINGER SWEEP. NO ADDITIONAL INTERVENTIONS OR CARE WERE NEEDED. THE TREATING SURGEON IS UNSURE WHY THERE WAS A SMALL MUCOSAL TEAR, AS NO RESISTANCE WAS ENCOUNTERED WHEN ENTERING THE PATIENT (SUSPECTED IT COULD BE DUE TO THE PATIENT BEING OLDER AND HAVING FRAGILE SKIN). THE TREATING SURGEON WILL BE SEEING THE PATIENT IN 2 WEEKS FOR A FOLLOW-UP. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Laceration(s)

  MAUDE report 24142168 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT THE PATIENT HAD A RECTAL PERFORATION. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY AND RECEIVED A COLOSTOMY. THE PATIENT IS REPORTED TO BE DOING FINE. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 23758825 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PRECEPT BECAME AWARE THAT POST-AQUABLATION THERAPY, THE PATIENT HAD A RECTAL PERFORATION. THE PATIENT WAS THEN TRANSFERRED TO A DIFFERENT FACILITY AND STAYED IN THE INTENSIVE CARE UNIT (ICU). CURRENTLY, THE PATIENT IS IN THE GENERAL SURGERY WARD TO SEE IF THE PERFORATION HEALS ITSELF OR IF SURGICAL REPAIR IS NEEDED. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 23623132 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT WENT SEPTIC. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR SEPSIS. THE PATIENT RECEIVED AN ABDOMINAL CT (COMPUTED TOMOGRAPHY) SCAN DUE TO THE INFECTION, AND A RECTAL INJURY WAS DETECTED. THE PATIENT THEN UNDERWENT SURGERY, AND AN ARTIFICIAL COLOSTOMY WAS APPLIED. THE PATIENT IS REPORTED TO BE DOING FINE. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Bowel Perforation; Sepsis

  MAUDE report 23375417 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE OF A RECTAL MUCOSAL TEAR WITH THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ITS ASSOCIATED ECBP-1 TRUS PROBE. THE TREATING SURGEON REPORTED THAT BLEEDING WAS NOTED AFTER ECBP-1 TRUS PROBE INSERTION. THE TREATING SURGEON DID A RECTAL EXAM POST ECBP-1 TRUS PROBE REMOVAL AND NOTED SMALL EXTERNAL MUCOSAL TEAR NEAR ANUS. THE TREATING SURGEON NOTED NO ISSUES WHEN DOING AN INTERNAL RECTAL FINGER SWEEP. NO ADDITIONAL INTERVENTIONS OR CARE WERE NEEDED. THE TREATING SURGEON IS UNSURE WHY THERE WAS A SMALL MUCOSAL TEAR, AS NO RESISTANCE WAS ENCOUNTERED WHEN ENTERING THE PATIENT (SUSPECTED IT COULD BE DUE TO THE PATIENT BEING OLDER AND HAVING FRAGILE SKIN). THE TREATING SURGEON WILL BE SEEING THE PATIENT IN 2 WEEKS FOR A FOLLOW-UP. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Laceration(s)

  MAUDE report 22324791 ↗
• OtherJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT THE PATIENT SUSTAINED A RECTAL PERFORATION DURING HEMOSTASIS. IT WAS NOTED THAT THE ECBP-1 TRUS PROBE REMAINED IN PLACE DURING HEMOSTASIS AND THE TREATING SURGEON RE-POSITIONED THE ECBP-1 TRUS PROBE APPROXIMATELY THREE (3) TIMES TO GIVE MORE SPACE FOR THE RESECTOSCOPE. DURING LOOP RESECTION AT THE POSTERIOR MID-FOSSA, THE TIP OF THE ECBP-1 TRUS PROBE WAS OBSERVED TO BE PROTRUDING THROUGH THE RECTAL WALL, INDICATING A RECTAL INJURY. EVALUATION FROM A DIFFERENT PHYSICIAN REPORTED THERE WAS A ~1CM OPENING. THE TREATING SURGEON CONFIRMED THAT THE PATIENT RECEIVED A ROBOTIC REPAIR THE SAME DAY AND WAS DISCHARGED THE FOLLOWING DAY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 22288365 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT A DAY POST-AQUABLATION THERAPY, THE PATIENT EXPRESSED ABDOMINAL PAIN TO THE TREATING SURGEON. A CT SCAN WAS PERFORMED WHICH CONFIRMED THAT THE OBSERVED FLUID WAS RELATED TO AN INFECTION. THE TREATING SURGEON STATED THAT THE PATIENT HAD A RECTAL PERFORATION AND REQUIRED A COLOSTOMY DIVERSION. NO RESISTANCE DURING THE INSERTION OF THE TRUS PROBE WAS REPORTED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 22129266 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT A DAY POST-AQUABLATION THERAPY, THE PATIENT EXPRESSED ABDOMINAL PAIN TO THE TREATING SURGEON. A CT SCAN WAS PERFORMED WHICH CONFIRMED THAT THE OBSERVED FLUID WAS RELATED TO AN INFECTION. THE TREATING SURGEON STATED THAT THE PATIENT HAD A RECTAL PERFORATION AND REQUIRED A COLOSTOMY DIVERSION. NO RESISTANCE DURING THE INSERTION OF THE TRUS PROBE WAS REPORTED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 22054911 ↗
• InjuryMar 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE OF A RECTAL MUCOSAL TEAR WITH THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ITS ASSOCIATED ECBP-1 TRUS PROBE AFTER AQUABLATION THERAPY HAD BEEN COMPLETED. BLOOD WAS NOTED ON THE PROBE WHEN THE TREATING SURGEON REMOVED THE ECBP-1 TRUS PROBE. THE TREATING SURGEON PROCEEDED TO PERFORM A DIGITAL RECTAL EXAM AND OBSERVED BLOOD ON HIS GLOVE. A COLORECTAL SURGEON WAS BROUGHT IN AND IDENTIFIED A MUCOSAL TEAR IN THE RECTUM. THE MUCOSAL TEAR WAS SUTURED. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THE TREATING SURGEON REPORTED THAT NO RESISTANCE WAS MET WHEN THE ECBP-1 TRUS PROBE WAS INSERTED IN THE PATIENT AND DID NOT MENTION THAT THERE WAS ANYTHING UNUSUAL WITH THE PATIENT'S ANATOMY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Laceration(s)

  MAUDE report 21671182 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE OF A RECTAL MUCOSAL TEAR WITH THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ITS ASSOCIATED ECBP-1 TRUS PROBE AFTER AQUABLATION THERAPY HAD BEEN COMPLETED. BLOOD WAS NOTED ON THE PROBE WHEN THE TREATING SURGEON REMOVED THE ECBP-1 TRUS PROBE. THE TREATING SURGEON PROCEEDED TO PERFORM A DIGITAL RECTAL EXAM AND OBSERVED BLOOD ON HIS GLOVE. A COLORECTAL SURGEON WAS BROUGHT IN AND IDENTIFIED A MUCOSAL TEAR IN THE RECTUM. THE MUCOSAL TEAR WAS SUTURED. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THE TREATING SURGEON REPORTED THAT NO RESISTANCE WAS MET WHEN THE ECBP-1 TRUS PROBE WAS INSERTED IN THE PATIENT AND DID NOT MENTION THAT THERE WAS ANYTHING UNUSUAL WITH THE PATIENT'S ANATOMY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Laceration(s)

  MAUDE report 21659829 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT DURING HEMOSTASIS, THE TREATING SURGEON NOTED THAT THE PATIENT'S RECTAL WALL WAS PERFORATED. AN ILEOSTOMY PROCEDURE WAS PERFORMED TO REPAIR THE PERFORATION. THE PATIENT HAS BEEN DISCHARGED AND WILL HAVE THE OSTOMY FOR APPROXIMATELY THREE MONTHS. IT WAS REPORTED THAT THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT'S ANATOMY. NO RESISTANCE DURING INSERTION OF THE TRUS PROBE WAS REPORTED. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 21023673 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT POST AQUABLATION THERAPY, THE PATIENT COMPLAINED OF PAIN. UPON INSPECTION, THE PATIENT'S ABDOMEN WAS NOTED TO BE DISTENDED AND COMPUTED TOMOGRAPHY (CT) IMAGING WITH CONTRACT WAS PERFORMED, REVEALING A RECTAL PERFORATION. ON (B)(6) 2024, AN EXPLORATORY LAPAROTOMY AND SUBSEQUENT BOWEL DIVERSION PROCEDURE WERE PERFORMED. THE PATIENT REMAINS HOSPITALIZED UNDER OBSERVATION AND A DISCHARGE PLAN HAS NOT YET BEEN DETERMINED. IT WAS REPORTED THAT NO ISSUES WERE EXPERIENCED DURING THE AQUABLATION THERAPY, AND THE PATIENT DID NOT HAVE ANYTHING UNUSUAL WITH HIS ANATOMY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 20637628 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT POST AQUABLATION THERAPY, THE PATIENT COMPLAINED OF PAIN. UPON INSPECTION, THE PATIENT¿S ABDOMEN WAS NOTED TO BE DISTENDED AND COMPUTED TOMOGRAPHY (CT) IMAGING WITH CONTRACT WAS PERFORMED, REVEALING A RECTAL PERFORATION. ON (B)(6) 2024, AN EXPLORATORY LAPAROTOMY AND SUBSEQUENT BOWEL DIVERSION PROCEDURE WERE PERFORMED. THE PATIENT REMAINS HOSPITALIZED UNDER OBSERVATION AND A DISCHARGE PLAN HAS NOT YET BEEN DETERMINED. IT WAS REPORTED THAT NO ISSUES WERE EXPERIENCED DURING THE AQUABLATION THERAPY, AND THE PATIENT DID NOT HAVE ANYTHING UNUSUAL WITH HIS ANATOMY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 20578645 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A MALE PATIENT WITH A HISTORY OF RECTUM DIVERTICULUM UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT TWO DAYS AFTER POST-AQUABLATION THERAPY, THE PATIENT BEGAN TO EXPERIENCE ABDOMINAL PAIN, AND A DIAGNOSTIC PROCEDURE WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE A RECTAL PERFORATION. THE PERFORATION WAS SURGICALLY REPAIRED. IT WAS REPORTED THAT THE CURRENT STATUS OF THE PATIENT IS UNKNOWN; HOWEVER, HE HAS BEEN DISCHARGED. IT WAS REPORTED THAT NO ISSUES WERE EXPERIENCED DURING THE AQUABLATION THERAPY, AND NO RESISTANCE WAS EXPERIENCED DURING ECBP-1 TRUS PROBE INSERTION. NO BLOOD WAS NOTED ON THE ECBP-1 TRUS PROBE WHEN IT WAS REMOVED FROM THE PATIENT'S RECTUM. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 20457955 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A MALE PATIENT WITH A HISTORY OF RECTUM DIVERTICULUM UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT TWO DAYS AFTER POST-AQUABLATION THERAPY, THE PATIENT BEGAN TO EXPERIENCE ABDOMINAL PAIN, AND A DIAGNOSTIC PROCEDURE WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE A RECTAL PERFORATION. THE PERFORATION WAS SURGICALLY REPAIRED. IT WAS REPORTED THAT THE CURRENT STATUS OF THE PATIENT IS UNKNOWN; HOWEVER, HE HAS BEEN DISCHARGED. IT WAS REPORTED THAT NO ISSUES WERE EXPERIENCED DURING THE AQUABLATION THERAPY, AND NO RESISTANCE WAS EXPERIENCED DURING ECBP-1 TRUS PROBE INSERTION. NO BLOOD WAS NOTED ON THE ECBP-1 TRUS PROBE WHEN IT WAS REMOVED FROM THE PATIENT¿S RECTUM. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 20377801 ↗
• InjuryJun 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). ON 01-MAY-2024 PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE OF AN UNSPECIFIED ADVERSE EVENT WHERE THE PATIENT WAS REPORTED TO HAVE UNDERGONE A COLORECTAL PROCEDURE FOLLOWING AQUABLATION THERAPY. AT THIS TIME, PROCEPT HAS BEEN UNABLE TO OBTAIN FURTHER INFORMATION, BUT IT IS SUSPECTED THAT A RECTAL INJURY OCCURRED, RESULTING IN THE COLORECTAL PROCEDURE. THE ONLY INFORMATION PROVIDED TO PROCEPT IS THAT THE PATIENT HAS BEEN DISCHARGED HOME AND THE TREATING SURGEON WAS UNABLE TO DETERMINE WHAT CAUSED THE INJURY. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

  Patient problems: Perforation

  MAUDE report 19443106 ↗
• InjuryDec 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE OF A PATIENT SUSTAINING A RECTAL PERFORATION DURING AN AQUABLATION PROCEDURE WITH THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ITS ASSOCIATED ECBP-1 TRUS PROBE. IT WAS REPORTED THAT THE TREATING SURGEON MET RESISTANCE WHILE INSERTING AND REPOSITIONING THE ECBP-1 TRUS PROBE INTO THE RECTUM. RESISTANCE WAS ALSO MET WHILE TRYING TO ADVANCE THE ECBP-1 TRUS PROBE WITHIN THE RECTAL CHANNEL. APPROXIMATELY 45 MINUTES INTO RESECTION, THE TREATING SURGEON INDICATED THAT HE COULD SEE THE ECBP-1 TRUS PROBE AT 5 O'CLOCK, LATERAL TO THE VERU ON THE LEFT SIDE. THIS IS INDICATIVE OF A PROSTATE CAPSULE PERFORATION. UPON REMOVAL OF THE ECBP-1 TRUS PROBE POST-AQUABLATION PROCEDURE BLOOD WAS NOTICED ON THE ENTIRETY OF THE ECBP-1 TRUS PROBE. FURTHER INVESTIGATION BY ULTRASOUND SUPPORT WAS UNABLE TO PRODUCE ADDITIONAL INFORMATION. THE TREATING SURGEON PERFORMED A DIGITAL RECTAL EVALUATION AND REQUESTED COLORECTAL SUPPORT. A COLORECTAL SURGEON SUTURED THE RECTUM TO REPAIR THE PERFORATION. THE RECTAL PERFORATION IS BELIEVED TO HAVE O

  Patient problems: Perforation

  MAUDE report 18422794 ↗