UNKNOWN
Report
- Report Number
- 2124215-2024-34588
- Event Type
- Injury
- Date Received
- June 11, 2024
- Date of Event
- January 1, 2011
- Report Date
- July 24, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ELSHERBINI T, BOUHADANA D, SADRI I, NGUYEN D-D, LAW KW, ARESKI A, DEYIRMENDJIAN C, IBRAHIM A, BHOJANI N, ELTERMAN DS, CHUGHTAI B, BRUYERE F, CINDOLO L, FERRARI G, VASQUEZ-LASTRA C, BORELLI-BOVO T, BECHER EF, CASH H, REIMANN M, RIJO E, MISRAI V, ZORN KC. THE IMPACT OF 5-ARO ON PERIOPERATIVE AND FUNCTIONAL OUTCOMES OF GREENLIGHT PVP: AN ANALYSIS OF GLOBAL GREENLIGHT GROUP DATABASE. CAN J UROL 2023;30(2):11473-11479.
ELSHERBINI T, BOUHADANA D, SADRI I, NGUYEN D-D, LAW KW, ARESKI A, DEYIRMENDJIAN C, IBRAHIM A, BHOJANI N, ELTERMAN DS, CHUGHTAI B, BRUYERE F, CINDOLO L, FERRARI G, VASQUEZ-LASTRA C, BORELLI-BOVO T, BECHER EF, CASH H, REIMANN M, RIJO E, MISRAI V, ZORN KC. THE IMPACT OF 5-ARO ON PERIOPERATIVE AND FUNCTIONAL OUTCOMES OF GREENLIGHT PVP: AN ANALYSIS OF GLOBAL GREENLIGHT GROUP DATABASE. CAN J UROL 2023;30(2):11473-11479.
IT WAS REPORTED IN THE CANADIAN JOURNAL OF UROLOGY THAT A STUDY WAS CONDUCTED TO INVESTIGATE THE IMPACT OF 5-ALPHA REDUCTASE INHIBITORS (5-ARI) ON THE PERIOPERATIVE AND FUNCTIONAL OUTCOMES OF 180-WATT XPS GREENLIGHT PHOTOVAPORIZATION OF THE PROSTATE (PVP) USING A LARGE INTERNATIONAL DATABASE. A RETROSPECTIVE REVIEW WAS CONDUCTED ON THE RECORDS OF 3,500 MEN WHO UNDERWENT GREENLIGHT PVP USING THE XPS-180W SYSTEM BETWEEN 2011 AND 2019. ALL PROCEDURES WERE CONDUCTED BY EIGHT EXPERIENCED UROLOGISTS FROM SEVEN INTERNATIONAL TERTIARY CENTERS IN CANADA, FRANCE, GERMANY, ITALY, MEXICO AND BRAZIL. ANALYSIS OF THE RECORD REVEALED 22 PATIENTS REQUIRED TRANSFUSIONS, 212 PATIENTS HAD HEMATURIA, AND 187 PATIENTS WERE RE-ADMITTED WITHIN 30 DAYS POST-PROCEDURE.
IT WAS REPORTED IN THE CANADIAN JOURNAL OF UROLOGY THAT A STUDY WAS CONDUCTED TO INVESTIGATE THE IMPACT OF 5-ALPHA REDUCTASE INHIBITORS (5-ARI) ON THE PERIOPERATIVE AND FUNCTIONAL OUTCOMES OF 180-WATT XPS GREENLIGHT PHOTOVAPORIZATION OF THE PROSTATE (PVP) USING A LARGE INTERNATIONAL DATABASE. A RETROSPECTIVE REVIEW WAS CONDUCTED ON THE RECORDS OF 3,500 MEN WHO UNDERWENT GREENLIGHT PVP USING THE XPS-180W SYSTEM BETWEEN 2011 AND 2019. ALL PROCEDURES WERE CONDUCTED BY EIGHT EXPERIENCED UROLOGISTS FROM SEVEN INTERNATIONAL TERTIARY CENTERS IN CANADA, FRANCE, GERMANY, ITALY, MEXICO AND BRAZIL. ANALYSIS OF THE RECORD REVEALED 22 PATIENTS REQUIRED TRANSFUSIONS, 212 PATIENTS HAD HEMATURIA, AND 187 PATIENTS WERE RE-ADMITTED WITHIN 30 DAYS POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153689 | UNKNOWN | POWERED LASER SURGICAL INSTRUMENT | GEX | BOSTON SCIENTIFIC CORPORATION | UNK-P-GREENLIGHT FIBER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | PROD: GREENLIGHT XPS LASER, UPN: 0010-0210| PROD: GREENLIGHT XPS LASER, UPN: 0010-0210 |