REZUM
Report
- Report Number
- 2124215-2025-54904
- Event Type
- Injury
- Date Received
- August 12, 2025
- Date of Event
- October 1, 2020
- Report Date
- September 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CITATION: JOSHUA W., REBECCA K., CASSIDY L., ALIA C., NAEEM B., DEAN E. (2025). QUALITY OF LIFE AND SURGICAL TREATMENT REGRETIN PATIENTS WITH BENIGN PROSTATIC HYPERTROPHY: A MULTICENTER STUDY. CANADIAN JOURNAL OF UROLOGY, 2025; 32 (3):219-227.
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A PRODUCT PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISKS ASSOCIATED WITH USE OF THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. MANUFACTURER REPORT INFORMATION G2 (REPORT SOURCE) CORRECTED MANUFACTURER REPORT INFORMATION G2 (REPORT SOURCE (OTHER)) UPDATED INITIAL REPORTER FIRST NAME, INITIAL REPORTER LAST NAME, INITIAL REPORTER FACILITY NAME, INITIAL REPORTER ADDRESS 1, INITIAL REPORTER CITY, INITIAL REPORTER STATE, INITIAL REPORTER COUNTRY, INITIAL REPORTER ZIP/POST CODE (E1) CORRECTED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CITATION: JOSHUA W., REBECCA K., CASSIDY L., ALIA C., NAEEM B., DEAN E. (2025). QUALITY OF LIFE AND SURGICAL TREATMENT REGRET IN PATIENTS WITH BENIGN PROSTATIC HYPERTROPHY: A MULTICENTER STUDY. CANADIAN JOURNAL OF UROLOGY, 2025; 32 (3):219-227.
IT WAS REPORTED IN THE CANADIAN JOURNAL OF UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO IDENTIFY PREOPERATIVE IPSS-QOL (INTERNATIONAL PROSTATE SYMPTOM SCORE QUALITY OF LIFE) FOR COMPARISON PURPOSES. A TOTAL OF 54 MALE PATIENTS WITH DIAGNOSIS OF BENIGN PROSTATIC HYPERPLASIA (BPH) WERE ENROLLED FROM OCTOBER 2020 TO MARCH 2023. THE FOLLOWING BOSTON SCIENTIFIC PRODUCTS WERE USED DURING THE PROCEDURES: REZUM DEVICE. REGARDING POSTOPERATIVE COMPLICATIONS, THE MOST COMMON REASONS FOR PROCEDURAL REGRET WERE INSUFFICIENT RELIEF OR CONTINUED SYMPTOMS AFTER SURGERY (9 PATIENTS); 2 PATIENTS EXPERIENCED DYSURIA, 4 PATIENTS WITH POLYURIA AND 2 PATIENTS DEVELOPED NOCTURIA. TWO PATIENTS WERE OBSERVED POST-OPERATIVE BLEEDING. IT WAS ALSO REPORTED THAT 3 PATIENT DEVELOPED ERECTILE DYSFUNCTION AND 2 PATIENTS NEEDED MULTIPLE SURGERIES. SURGICAL TREATMENT FOR BPH GENERALLY LEADS TO IMPROVEMENT IN SYMPTOMS, BUT A SIGNIFICANT SUBSET OF PATIENTS EXPERIENCES DECISIONAL REGRET, PARTICULARLY IN CASES OF PERCEIVED PROCEDURE INEFFICACY OR POSTOPERATIVE COMPLICATIONS. THIS IS CONSISTENT WITH THE OBSERVED CORRELATION BETWEEN INCREASED SYMPTOMATIC IMPROVEMENT AND DECREASED PROCEDURAL REGRET.
IT WAS REPORTED IN THE CANADIAN JOURNAL OF UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO IDENTIFY PREOPERATIVE IPSS-QOL (INTERNATIONAL PROSTATE SYMPTOM SCORE QUALITY OF LIFE) FOR COMPARISON PURPOSES. A TOTAL OF 54 MALE PATIENTS WITH DIAGNOSIS OF BENIGN PROSTATIC HYPERPLASIA (BPH) WERE ENROLLED FROM OCTOBER 2020 TO MARCH 2023. THE FOLLOWING BOSTON SCIENTIFIC PRODUCTS WERE USED DURING THE PROCEDURES: REZUM DEVICE. REGARDING POSTOPERATIVE COMPLICATIONS, THE MOST COMMON REASONS FOR PROCEDURAL REGRET WERE INSUFFICIENT RELIEF OR CONTINUED SYMPTOMS AFTER SURGERY (9 PATIENTS); 2 PATIENTS EXPERIENCED DYSURIA, 4 PATIENTS WITH POLYURIA AND 2 PATIENTS DEVELOPED NOCTURIA. TWO PATIENTS WERE OBSERVED POST-OPERATIVE BLEEDING. IT WAS ALSO REPORTED THAT 3 PATIENT DEVELOPED ERECTILE DYSFUNCTION AND 2 PATIENTS NEEDED MULTIPLE SURGERIES. SURGICAL TREATMENT FOR BPH GENERALLY LEADS TO IMPROVEMENT IN SYMPTOMS, BUT A SIGNIFICANT SUBSET OF PATIENTS EXPERIENCES DECISIONAL REGRET, PARTICULARLY IN CASES OF PERCEIVED PROCEDURE INEFFICACY OR POSTOPERATIVE COMPLICATIONS. THIS IS CONSISTENT WITH THE OBSERVED CORRELATION BETWEEN INCREASED SYMPTOMATIC IMPROVEMENT AND DECREASED PROCEDURAL REGRET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2364138 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |