REZUM
Report
- Report Number
- 2124215-2026-04596
- Event Type
- Injury
- Date Received
- January 26, 2026
- Date of Event
- January 1, 2023
- Report Date
- February 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. KLEIN, C., ANRACT, J., PINAR, U., CHEVROT, A., DELLA NEGRA, E., FASSI-FEHRI, H., GAS, J., ROUSCOFF, Y., WILISCH, J., SARAZIN, C., DOIZI, S., & LEBDAI, S. (2025). SURGICAL AND INTERVENTIONAL MANAGEMENT OF BLADDER OUTLET OBSTRUCTION RELATED TO BENIGN PROSTATIC HYPERPLASIA: SYSTEMATIC REVIEW OF THE LITERATURE AND CLINICAL PRACTICE GUIDELINES FROM THE FRENCH MALE LUTS COMMITTEE (CTMH). THE FRENCH JOURNAL OF UROLOGY, 35(11), 102951. HTTPS://DOI.ORG/10.1016/J.FJUROL.2025.102951.
THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. 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 UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. KLEIN, C., ANRACT, J., PINAR, U., CHEVROT, A., DELLA NEGRA, E., FASSI-FEHRI, H., GAS, J., ROUSCOFF, Y., WILISCH, J., SARAZIN, C., DOIZI, S., & LEBDAI, S. (2025). SURGICAL AND INTERVENTIONAL MANAGEMENT OF BLADDER OUTLET OBSTRUCTION RELATED TO BENIGN PROSTATIC HYPERPLASIA: SYSTEMATIC REVIEW OF THE LITERATURE AND CLINICAL PRACTICE GUIDELINES FROM THE FRENCH MALE LUTS COMMITTEE (CTMH). THE FRENCH JOURNAL OF UROLOGY, 35(11), 102951. HTTPS://DOI.ORG/10.1016/J.FJUROL.2025.102951.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE FRENCH JOURNAL OF UROLOGY THAT A SYSTEMATIC REVIEW WAS CONDUCTED TO UPDATE THE FRENCH RECOMMENDATIONS PUBLISHED IN 2021, AS WELL AS THE 2024 EUROPEAN ASSOCIATION OF UROLOGY GUIDELINES, ON THE SURGICAL AND INTERVENTIONAL MANAGEMENT OF BLADDER OUTLET OBSTRUCTION RELATED TO BENIGN PROSTATIC HYPERPLASIA. THE REVIEW OF THE LITERATURE WAS PERFORMED THROUGH PUBMED FROM 2023-2025, COMPLEMENTING THE DATA ALREADY INCLUDED IN PREVIOUS GUIDELINES. THIS PROCESS WAS BASED ON A PREDEFINED BIBLIOGRAPHIC STRATEGY, FOLLOWED BY A CRITICAL ANALYZE OF THE PUBLICATIONS WITH ASSIGNMENT OF LEVELS OF EVIDENCE, FORMULATION OF CONCLUSIONS, AND DEVELOPMENT OF RECOMMENDATIONS ADDRESSING SPECIFIC CLINICAL QUESTIONS. FOR REZUM PROCEDURES, AN ADVERSE EVENT EXPERIENCED BY THE PATIENTS WAS ACUTE URINARY RETENTION, AND SURGICAL RETREATMENT AND MEDICATION RESTART WERE REQUIRED. REZUM MAY BE OFFERED AS A SURGICAL OPTION FOR MEN WITH MODERATE-TO-SEVERE LUTS, DESIRING EJACULATORY PRESERVATION, AND WITH PROSTATE VOLUMES OF 30-80 ML.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE FRENCH JOURNAL OF UROLOGY THAT A SYSTEMATIC REVIEW WAS CONDUCTED TO UPDATE THE FRENCH RECOMMENDATIONS PUBLISHED IN 2021, AS WELL AS THE 2024 EUROPEAN ASSOCIATION OF UROLOGY GUIDELINES, ON THE SURGICAL AND INTERVENTIONAL MANAGEMENT OF BLADDER OUTLET OBSTRUCTION RELATED TO BENIGN PROSTATIC HYPERPLASIA. THE REVIEW OF THE LITERATURE WAS PERFORMED THROUGH PUBMED FROM 2023-2025, COMPLEMENTING THE DATA ALREADY INCLUDED IN PREVIOUS GUIDELINES. THIS PROCESS WAS BASED ON A PREDEFINED BIBLIOGRAPHIC STRATEGY, FOLLOWED BY A CRITICAL ANALYZE OF THE PUBLICATIONS WITH ASSIGNMENT OF LEVELS OF EVIDENCE, FORMULATION OF CONCLUSIONS, AND DEVELOPMENT OF RECOMMENDATIONS ADDRESSING SPECIFIC CLINICAL QUESTIONS. FOR REZUM PROCEDURES, AN ADVERSE EVENT EXPERIENCED BY THE PATIENTS WAS ACUTE URINARY RETENTION, AND SURGICAL RETREATMENT AND MEDICATION RESTART WERE REQUIRED. REZUM MAY BE OFFERED AS A SURGICAL OPTION FOR MEN WITH MODERATE-TO-SEVERE LUTS, DESIRING EJACULATORY PRESERVATION, AND WITH PROSTATE VOLUMES OF 30-80 ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 246981 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |