REZUM
Report
- Report Number
- 2124215-2026-04983
- Event Type
- Injury
- Date Received
- January 28, 2026
- Date of Event
- January 6, 2026
- Report Date
- February 25, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729996996
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE MET WITH ALL MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.
B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED.
IT WAS REPORTED THAT A PATIENT UNDERWENT TO A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA AND THE PROCEDURE WENT TO PLANT, WITHOUT PROBLEM. UPON ROUTINE FOLLOW UP APPOINTMENT, THE PATIENT PRESENTED UROSEPSIS AND RETENTION AFTER THE INDWELLING CATHETER (IDC) WAS OUT, THEREFORE THE IDC WAS RECOMMENDED FOR TEN DAYS MORE. THE PATIENT WAS ADMITTED FOR INTRAVENOUS (IV) ANTIBIOTICS AND LATER DISCHARGED. AFTER THAT, THE PATIENT IS USING ORAL ANTIBIOTICS FOR A MULTI RESISTANT BUG DUE TO THE INFECTION. THE PATIENT WAS ON KEFLEX FOR 10 DAYS AND HAD GENT; HOWEVER, HE DID NOT HAVE KEFLEX POST CATHETER REMOVAL. THE PATIENT OUTCOME IS EXPECTED TO FULLY RECOVER.
IT WAS REPORTED THAT A PATIENT UNDERWENT TO A WATER VAPOR THERAPY PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA AND THE PROCEDURE WENT TO PLANT, WITHOUT PROBLEM. UPON ROUTINE FOLLOW UP APPOINTMENT, THE PATIENT PRESENTED UROSEPSIS AND RETENTION AFTER THE INDWELLING CATHETER (IDC) WAS OUT, THEREFORE THE IDC WAS RECOMMENDED FOR TEN DAYS MORE. THE PATIENT WAS ADMITTED FOR INTRAVENOUS (IV) ANTIBIOTICS AND LATER DISCHARGED. AFTER THAT, THE PATIENT IS USING ORAL ANTIBIOTICS FOR A MULTI RESISTANT BUG DUE TO THE INFECTION. THE PATIENT WAS ON KEFLEX FOR 10 DAYS AND HAD GENT; HOWEVER, HE DID NOT HAVE KEFLEX POST CATHETER REMOVAL. THE PATIENT OUTCOME IS EXPECTED TO FULLY RECOVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371797 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | D2201 | 0036868559 | 08714729996996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |