SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

Additional Manufacturer Narrative

PROCEPT BIOROBOTICS IS AN IMPORTER OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM. THE RECEIVING INSPECTION RECORD FOR THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM SERIAL NUMBER: (B)(6) WAS REVIEWED. IT PASSED THE RECEIVING INSPECTION. NO REWORKS WERE PERFORMED BY PROCEPT BIOROBOTICS THAT WERE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE REVIEW OF THE OPERATION MANUAL FOR THE APOGEE 2300 DEVICE (IFU) FOUND THAT IT HAS COVERED THE RELATED SAFETY INSTRUCTION: 1.6 SAFETY: L) WHEN PERFORMING THE RECTAL ULTRASOUND EXAM, BE GENTLE IN THE MOVEMENT. DO NOT PERFORM VIOLENT OPERATION, OTHERWISE IT MAY CAUSE RISKS OF PERFORATION OF THE RECTAL WALL, DAMAGE TO THE ANUS AND PERIANAL TISSUES, DAMAGE TO THE RECTAL MUCOSA OR BLEEDING. IN SUMMARY, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE USER MANUAL OF THE APOGEE 2300 DEVICE LISTS RECTAL PERFORATION AS A POTENTIAL RISK OF THE PROCEDURE. BASED ON THE REVIEW OF TREATMENT LOG FILES, DHR, POST-MARKETING DATA AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. THE INFORMATION RECEIVED DETERMINED THAT THE RECTAL PERFORATION WAS NOT RELATED TO THE SIUI APOGEE 2300 DEVICE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. BASED ON THE ANALYSIS OF MEDICAL DEVICE REPORTING DATABASES IN REGIONS SUCH AS CHINA, AUSTRALIA AND CANADA, AS WELL AS CUSTOMER FEEDBACK DATA FROM MARKETS WHERE THE APOGEE 2300 AND ECBP-1 DEVICES HAVE BEEN RELEASED, IT CAN BE CONCLUDED THAT THERE WERE NO DESIGN DEFECTS IN THE APOGEE 2300 AND ECBP-1 DEVICES RESULTING IN SUCH INCIDENT; BASED ON THE REVIEW OF THE DHF OF THE MEDICAL DEVICES WITH THE SNS REPORTED IN THIS INCIDENT, IT CAN BE CONFIRMED THAT THE CORRESPONDING APOGEE 2300 AND ECBP-1 WERE IN COMPLIANCE WITH THE PRODUCT QUALITY REQUIREMENTS.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE SURGEON INSERTED THE TRUS PROBE INTO THE PATIENT'S RECTUM AND MET RESISTANCE RIGHT AWAY; HE PULLED IT OUT, AND A LARGE BLOOD CLOT AND FRESH BLOOD CAME OUT OF THE RECTUM. GENERAL SURGERY WAS CALLED, AND THEY FOUND THAT THE PATIENT HAD A SMALL SUPERFICIAL TEAR IN THE RECTUM. THEY PATCHED IT UP, AND THE CASE WAS CONVERTED TO A TRANS URETHRAL RESECTION OF THE PROSTATE (TURP) BECAUSE IT WAS NOT SAFE TO USE THE TRUS PROBE. THE PATIENT HAD A LONG HISTORY OF COLON SURGERIES AND HAD A COLOSTOMY BAG. THE SURGEON WAS UNSURE IF THE TEAR WAS CAUSED BY A DIGITAL RECTAL EXAM(DRE) OR THE TRUS PROBE BECAUSE THE PATIENT'S RECTAL WALL WAS SO WEAK. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.