VERSAPULSE POWERSUITE
Report
- Report Number
- 2124215-2025-31268
- Event Type
- Injury
- Date Received
- June 2, 2025
- Date of Event
- February 16, 2024
- Report Date
- June 26, 2025
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K170121
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 02/16/2024, WAS CHOSEN AS THE BEST ESTIMATE BASED ON YEAR THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE CHOI, S. M., KANG, C. S., KIM, D. H., CHOI, J. H., LEE, C., JEH, S. U., KAM, S. C., HWA, J. S., & HYUN, J. S. (2024). CLINICAL OUTCOME AND SAFETY OF HOLMIUM LASER PROSTATE ENUCLEATION AFTER TRANSRECTAL PROSTATE BIOPSIES FOR BENIGN PROSTATIC HYPERPLASIA. INVESTIGATIVE AND CLINICAL UROLOGY, 65(148-156). HTTPS://DOI.ORG/10.4111/ICU.20230276.
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. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF THE DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTION FOR USE. BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 02/16/2024, WAS CHOSEN AS THE BEST ESTIMATE BASED ON YEAR THE ARTICLE WAS PUBLISHED. BLOCK G2: LITERATURE SOURCE CHOI, S. M., KANG, C. S., KIM, D. H., CHOI, J. H., LEE, C., JEH, S. U., KAM, S. C., HWA, J. S., & HYUN, J. S. (2024). CLINICAL OUTCOME AND SAFETY OF HOLMIUM LASER PROSTATE ENUCLEATION AFTER TRANSRECTAL PROSTATE BIOPSIES FOR BENIGN PROSTATIC HYPERPLASIA. INVESTIGATIVE AND CLINICAL UROLOGY, 65(148-156). HTTPS://DOI.ORG/10.4111/ICU.20230276
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL INVESTIGATIVE AND CLINICAL UROLOGY, THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE CLINICAL OUTCOME AND SAFETY OF HOLMIUM LASER PROSTATE ENUCLEATION AFTER TRANSRECTAL PROSTATE BIOPSIES FOR BENIGN PROSTATIC HYPERPLASIA. A RETROSPECTIVE ANALYSIS FROM 556 PATIENTS WHO UNDERWENT HOLEP BETWEEN 2014 AND 2021 WAS CONDUCTED. THE PATIENTS WERE CATEGORIZED INTO SIX GROUPS: GROUP 1-A (N=45) UNDERWENT HOLEP WITHIN FOUR MONTHS POST TR BIOPSY. GROUP 1-B (N=94) UNDERWENT HOLEP MORE THAN FOUR MONTHS POST TR BIOPSY. GROUP 1-C (N=120) UNDERWENT HOLEP AFTER A SINGLE TR BIOPSY. GROUP 1-D (N=19) UNDERWENT HOLEP AFTER TWO OR MORE TR BIOPSIES. GROUP 1-TOTAL (N=139, GROUP 1-A+GROUP 1-B OR GROUP 1-C+GROUP 1-D) UNDERWENT HOLEP POST TR BIOPSY. GROUP 2 (CONTROL GROUP, N=417) UNDERWENT HOLEP WITHOUT PRIOR TR BIOPSY. A SINGLE SURGEON PERFORMED ALL OPERATIONS USING A 100-WATT HOLMIUM: YTTRIUM-ALUMINUM-GARNET (HO-YAG) LASER DEVICE WITH 550-MICRON END-FIRING LASER FIBERS (VERSAPULSE POWERSUITE; LUMENIS MEDICAL SYSTEMS) AND A VERSACUT TIS SUE MORCELLATOR (LUMENIS MEDICAL SYSTEMS). THE PERIOPERATIVE PARAMETERS, SAFETY, AND FUNCTIONAL OUTCOMES WERE EXAMINED. THE STATISTICAL RESULTS FROM THE STUDY NOTED THAT POSTOPERATIVE COMPLICATIONS SUCH AS URETHRAL STRICTURE, BLADDER NECK CONTRACTURE, INCONTINENCE OF MORE THAN THREE MONTHS, AND BLADDER INJURY BY A MORCELLATOR DID NOT DIFFER SIGNIFICANTLY BETWEEN GROUP 1-TOTAL AND GROUP 2. THEY WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN GROUPS 1-A AND 1-B OR BETWEEN GROUPS 1-C AND 1-D (P>0.05). POSTOPERATIVE MEDICATIONS OF ALPHA-BLOCKER, CHOLINERGIC, ANTIDIURETICS, AND DAILY PDE-5 (PHOSPHODIESTERS 5) INHIBITORS WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS EITHER. HOWEVER, POSTOPERATIVE MEDICATION OF ANTICHOLINERGICS OR BETA-3 AGONISTS WAS SIGNIFICANTLY HIGHER IN GROUP 2 (P<0.05). POSTOPERATIVE COMPLICATIONS SUCH AS URETHRAL STRICTURE, BLADDER NECK CONTRACTURE, INCONTINENCE OF MORE THAN THREE MONTHS, AND BLADDER INJURY BY A MORCELLATOR DID NOT DIFFER SIGNIFICANTLY BETWEEN GROUP 1-TOTAL AND GROUP 2. THEY WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN GROUPS 1-A AND 1-B OR BETWEEN GROUPS 1-C AND 1-D (P>0.05). POSTOPERATIVE MEDICATIONS OF ALPHA-BLOCKER, CHOLINERGIC, ANTIDIURETICS, AND DAILY PDE-5 (PHOSPHODIESTERS 5) INHIBITORS WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS EITHER. HOWEVER, POSTOPERATIVE MEDICATION OF ANTICHOLINERGICS OR BETA-3 AGONISTS WAS SIGNIFICANTLY HIGHER IN GROUP 2 (P<0.05). THIS EVENT CAPTURES THE PROCEDURES PERFORMED WITH THE VERSA PULSE POWER SUITE.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL INVESTIGATIVE AND CLINICAL UROLOGY, THAT A RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE CLINICAL OUTCOME AND SAFETY OF HOLMIUM LASER PROSTATE ENUCLEATION AFTER TRANSRECTAL PROSTATE BIOPSIES FOR BENIGN PROSTATIC HYPERPLASIA. A RETROSPECTIVE ANALYSIS FROM 556 PATIENTS WHO UNDERWENT HOLEP BETWEEN 2014 AND 2021 WAS CONDUCTED. THE PATIENTS WERE CATEGORIZED INTO SIX GROUPS: GROUP 1-A (N=45) UNDERWENT HOLEP WITHIN FOUR MONTHS POST TR BIOPSY. GROUP 1-B (N=94) UNDERWENT HOLEP MORE THAN FOUR MONTHS POST TR BIOPSY. GROUP 1-C (N=120) UNDERWENT HOLEP AFTER A SINGLE TR BIOPSY. GROUP 1-D (N=19) UNDERWENT HOLEP AFTER TWO OR MORE TR BIOPSIES. GROUP 1-TOTAL (N=139, GROUP 1-A+GROUP 1-B OR GROUP 1-C+GROUP 1-D) UNDERWENT HOLEP POST TR BIOPSY. GROUP 2 (CONTROL GROUP, N=417) UNDERWENT HOLEP WITHOUT PRIOR TR BIOPSY. A SINGLE SURGEON PERFORMED ALL OPERATIONS USING A 100-WATT HOLMIUM: YTTRIUM-ALUMINUM-GARNET (HO-YAG) LASER DEVICE WITH 550-MICRON END-FIRING LASER FIBERS (VERSAPULSE POWERSUITE; LUMENIS MEDICAL SYSTEMS) AND A VERSACUT TIS SUE MORCELLATOR (LUMENIS MEDICAL SYSTEMS). THE PERIOPERATIVE PARAMETERS, SAFETY, AND FUNCTIONAL OUTCOMES WERE EXAMINED. THE STATISTICAL RESULTS FROM THE STUDY NOTED THAT POSTOPERATIVE COMPLICATIONS SUCH AS URETHRAL STRICTURE, BLADDER NECK CONTRACTURE, INCONTINENCE OF MORE THAN THREE MONTHS, AND BLADDER INJURY BY A MORCELLATOR DID NOT DIFFER SIGNIFICANTLY BETWEEN GROUP 1-TOTAL AND GROUP 2. THEY WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN GROUPS 1-A AND 1-B OR BETWEEN GROUPS 1-C AND 1-D (P>0.05). POSTOPERATIVE MEDICATIONS OF ALPHA-BLOCKER, CHOLINERGIC, ANTIDIURETICS, AND DAILY PDE-5 (PHOSPHODIESTERS 5) INHIBITORS WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS EITHER. HOWEVER, POSTOPERATIVE MEDICATION OF ANTICHOLINERGICS OR BETA-3 AGONISTS WAS SIGNIFICANTLY HIGHER IN GROUP 2 (P<0.05). POSTOPERATIVE COMPLICATIONS SUCH AS URETHRAL STRICTURE, BLADDER NECK CONTRACTURE, INCONTINENCE OF MORE THAN THREE MONTHS, AND BLADDER INJURY BY A MORCELLATOR DID NOT DIFFER SIGNIFICANTLY BETWEEN GROUP 1-TOTAL AND GROUP 2. THEY WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN GROUPS 1-A AND 1-B OR BETWEEN GROUPS 1-C AND 1-D (P>0.05). POSTOPERATIVE MEDICATIONS OF ALPHA-BLOCKER, CHOLINERGIC, ANTIDIURETICS, AND DAILY PDE-5 (PHOSPHODIESTERS 5) INHIBITORS WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS EITHER. HOWEVER, POSTOPERATIVE MEDICATION OF ANTICHOLINERGICS OR BETA-3 AGONISTS WAS SIGNIFICANTLY HIGHER IN GROUP 2 (P<0.05). THIS EVENT CAPTURES THE PROCEDURES PERFORMED WITH THE VERSA PULSE POWER SUITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851683 | VERSAPULSE POWERSUITE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-VPPS_SERIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |