VERSAPULSE POWERSUITE
Report
- Report Number
- 2124215-2025-34092
- Event Type
- Injury
- Date Received
- June 3, 2025
- Date of Event
- January 1, 2022
- Report Date
- July 10, 2025
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K170121
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
JIANG, B., LIANG, P., WU, Y., WANG, W., SHEN, L. (2024). SAFETY AND EFFICACY OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE VERSUS BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL. LANGENBECK'S ARCHIVES OF SURGERY, 409(1), 313. HTTPS://DOI.ORG/10.1007/S00423-024-03499-2. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL 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.
JIANG, B., LIANG, P., WU, Y., WANG, W., SHEN, L. (2024). SAFETY AND EFFICACY OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE VERSUS BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL. LANGENBECK'S ARCHIVES OF SURGERY, 409(1), 313. HTTPS://DOI.ORG/10.1007/S00423-024-03499-2. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL 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. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE LANGENBECK'S ARCHIVES OF SURGERY THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFICACY OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) COMPARED TO BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE (BTUR-P) IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). A TOTAL OF 220 PATIENTS WHO WERE HOSPITALIZED FROM JANUARY 2022 TO SEPTEMBER 2023 WERE INCLUDED IN THIS STUDY. THESE PATIENTS WERE RANDOMLY ASSIGNED TO HOLEP (VERSA PULSE 100 W/SLIMLINE 550 UM HOLMIUM LASER FIBER) AND BTUR-P GROUPS, WITH 110 PARTICIPANTS IN EACH GROUP. PROSTATE TISSUE WAS MORCELLATED BY THE VERSACUT TISSUE MORCELLATOR SYSTEM. PREOPERATIVE GENERAL INFORMATION, PERIOPERATIVE DATA, COMPLICATIONS, AND POSTOPERATIVE FOLLOW-UP INDICATORS FROM BOTH GROUPS OF PATIENTS WAS COLLECTED. THE BASELINE CHARACTERISTICS OF PATIENTS IN BOTH GROUPS WERE SIMILAR, WITH NO STATISTICAL SIGNIFICANCE. COMPARED TO THE BTUR-P GROUP, THE HOLEP GROUP EXHIBITED SIGNIFICANTLY LESS INTRAOPERATIVE BLEEDING, SHORTER BLADDER IRRIGATION TIME, SHORTER CATHETER RETENTION TIME, AND REDUCED POSTOPERATIVE HOSPITALIZATION. ADDITIONALLY, THE PAIN SCORE DURING URINATION AFTER CATHETER REMOVAL WAS SIGNIFICANTLY LOWER IN THE HOLEP GROUP. POSTOPERATIVE COMPLICATIONS OCCURRED IN BOTH GROUPS; HOWEVER, THEY WERE LESS FREQUENT IN THE HOLEP GROUP (4 CASES), PRIMARILY CONSISTING OF URINARY RETENTION AND POSTOPERATIVE BLEEDING. THE BTUR-P GROUP EXPERIENCED MORE COMPLICATIONS (9 CASES). SIGNIFICANT REDUCTIONS IN POSTOPERATIVE RESIDUAL URINE VOLUME (RUV) WERE OBSERVED IN BOTH GROUPS. BOTH GROUPS ALSO SHOWED SIGNIFICANT IMPROVEMENTS IN QUALITY OF LIFE (QOL) SCORES AND INTERNATIONAL PROSTATE SYMPTOM SCORES (IPSS), WITH THE HOLEP GROUP DEMONSTRATING A MORE SIGNIFICANT DECREASE IN IPSS. AFTER COMPREHENSIVE EVALUATION, HOLEP WAS SUPERIOR TO BTUR-P IN TERMS OF SAFETY AND EFFICACY. THEREFORE, HOLEP MAY BE A PREFERABLE CHOICE FOR THE TREATMENT OF BPH.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE LANGENBECK'S ARCHIVES OF SURGERY THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFICACY OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) COMPARED TO BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE (BTUR-P) IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). A TOTAL OF 220 PATIENTS WHO WERE HOSPITALIZED FROM JANUARY 2022 TO SEPTEMBER 2023 WERE INCLUDED IN THIS STUDY. THESE PATIENTS WERE RANDOMLY ASSIGNED TO HOLEP (VERSA PULSE 100 W/SLIMLINE 550 UM HOLMIUM LASER FIBER) AND BTUR-P GROUPS, WITH 110 PARTICIPANTS IN EACH GROUP. PROSTATE TISSUE WAS MORCELLATED BY THE VERSACUT TISSUE MORCELLATOR SYSTEM. PREOPERATIVE GENERAL INFORMATION, PERIOPERATIVE DATA, COMPLICATIONS, AND POSTOPERATIVE FOLLOW-UP INDICATORS FROM BOTH GROUPS OF PATIENTS WAS COLLECTED. THE BASELINE CHARACTERISTICS OF PATIENTS IN BOTH GROUPS WERE SIMILAR, WITH NO STATISTICAL SIGNIFICANCE. COMPARED TO THE BTUR-P GROUP, THE HOLEP GROUP EXHIBITED SIGNIFICANTLY LESS INTRAOPERATIVE BLEEDING, SHORTER BLADDER IRRIGATION TIME, SHORTER CATHETER RETENTION TIME, AND REDUCED POSTOPERATIVE HOSPITALIZATION. ADDITIONALLY, THE PAIN SCORE DURING URINATION AFTER CATHETER REMOVAL WAS SIGNIFICANTLY LOWER IN THE HOLEP GROUP. POSTOPERATIVE COMPLICATIONS OCCURRED IN BOTH GROUPS; HOWEVER, THEY WERE LESS FREQUENT IN THE HOLEP GROUP (4 CASES), PRIMARILY CONSISTING OF URINARY RETENTION AND POSTOPERATIVE BLEEDING. THE BTUR-P GROUP EXPERIENCED MORE COMPLICATIONS (9 CASES). SIGNIFICANT REDUCTIONS IN POSTOPERATIVE RESIDUAL URINE VOLUME (RUV) WERE OBSERVED IN BOTH GROUPS. BOTH GROUPS ALSO SHOWED SIGNIFICANT IMPROVEMENTS IN QUALITY OF LIFE (QOL) SCORES AND INTERNATIONAL PROSTATE SYMPTOM SCORES (IPSS), WITH THE HOLEP GROUP DEMONSTRATING A MORE SIGNIFICANT DECREASE IN IPSS. AFTER COMPREHENSIVE EVALUATION, HOLEP WAS SUPERIOR TO BTUR-P IN TERMS OF SAFETY AND EFFICACY. THEREFORE, HOLEP MAY BE A PREFERABLE CHOICE FOR THE TREATMENT OF BPH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851960 | VERSAPULSE POWERSUITE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-VPPS_SERIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | SLIMLINE FIBERS.| SLIMLINE FIBERS.| VERSACUT MORCELLATOR.| VERSACUT MORCELLATOR. |