VERSACUT
Report
- Report Number
- 2124215-2024-32415
- Event Type
- Injury
- Date Received
- May 30, 2024
- Date of Event
- January 1, 2022
- Report Date
- July 8, 2024
- Manufacturer
- LUMENIS LTD
- Product Code
- GCJ
- PMA / PMN Number
- K050639
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED. CHEN Y, XU H, GAO D, ET AL. A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT AND SAFETY OF PIRANHA AND VERSACUT MORCELLATION DEVICES IN TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE. INT UROL NEPHROL. NOV 2022;54(11):2977-2981. DOI:10.1007/S11255-022-03218-0 WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT REPORTED COMPLAINT COULD NOT BE CONFIRMED, DUE TO THE DEVICE DID NOT RETURN. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS AND THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE CLINICAL EVENTS REPORTED OF TISSUE DAMAGE AND SERIOUS INJURY/ ILLNESS/ IMPAIRMENT ARE A KNOWN INHERENT RISK OF DEVICE USE AS STATED IN THE INSTRUCTIONS FOR USE (IFU). ALSO, THE PATIENT EFFECT UNINTENDED MORCELLATION OF NONTARGET TISSUES IS STATED IN THE RISK DOCUMENTATION. BASED ON ALL THE INFORMATION AVAILABLE, KNOWN INHERENT RISK OF DEVICE WAS THE CONCLUSION CODE ASSIGNED TO THIS INVESTIGATION.
B3. DATE OF EVENT THE EXACT DATE OF THE EVENT IS UNKNOWN, ESTIMATED. CHEN Y, XU H, GAO D, ET AL. A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT AND SAFETY OF PIRANHA AND VERSACUT MORCELLATION DEVICES IN TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE. INT UROL NEPHROL. NOV 2022;54(11):2977-2981. DOI:10.1007/S11255-022-03218-0.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE PUBLISHED IN INTERNATIONAL UROLOGY AND NEPHROLOGY THAT A STUDY NAMED A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT AND SAFETY OF PIRANHA AND VERSACUT MORCELLATION DEVICES IN TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE, WAS CONDUCTED TO ANALYZE THE EFFICIENCY AND SAFETY USE OF TWO DIFFERENT MORCELLATOR SYSTEMS IN MEN THAT WERE UNDER A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA. THE TWO SYSTEMS REVIEWED WERE THE VERSACUT MORCELLATOR AND THE PIRANHA MORCELLATOR. A TOTAL OF 210 PATIENTS WERE INCLUDED IN THE STUDY, AND THE GROUP WAS DIVIDED IN TWO SUBGROUPS, ONE PER EACH MORCELLATOR SYSTEM. THE PRINCIPAL OUTCOME GOAL OF THE STUDY WAS THE MORCELLATION EFFICIENCY, AND ALSO INDWELLING CATHETER TIME, CONTINUOUS BLADDER IRRIGATION TIME, BLADDER INJURY RATE, DEVICE FAILURE RATE, INCIDENCE OF DIFFICULT CRUSHING AND SUCTION, AND INCIDENCE OF URINARY RETENTION CAUSED BY TISSUE RESIDUE. IN REGARDS OF THE RESULTS, THE MORCELLATION TIME AND RATE WERE SIMILAR WITH BOTH SYSTEMS WHEN THE PROSTATE VOLUME WAS UNDER OR EQUAL TO 60ML, BUT FOR PROSTATE VOLUME OVER 60 ML THE PIRANHA MORCELLATOR SHOWED A SHORTER MORCELLATION TIME AND A HIGHER MORCELLATION RATE. ADDITIONALLY, THE PIRANHA MORCELLATOR PRESENTED MORE MECHANICAL FAILURE RATE AND THE RATE OF DIFFICULTY IN MORCELLATION WAS HIGHER WITH VERSACUT SYSTEM, ALSO WITH BOTH SYSTEMS THE BLADDER MUCOSAL INJURY RATE ON PATIENTS WAS SIMILAR.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE PUBLISHED IN INTERNATIONAL UROLOGY AND NEPHROLOGY THAT A STUDY NAMED A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT AND SAFETY OF PIRANHA AND VERSACUT MORCELLATION DEVICES IN TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE, WAS CONDUCTED TO ANALYZE THE EFFICIENCY AND SAFETY USE OF TWO DIFFERENT MORCELLATOR SYSTEMS IN MEN THAT WERE UNDER A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA. THE TWO SYSTEMS REVIEWED WERE THE VERSACUT MORCELLATOR AND THE PIRANHA MORCELLATOR. A TOTAL OF 210 PATIENTS WERE INCLUDED IN THE STUDY, AND THE GROUP WAS DIVIDED IN TWO SUBGROUPS, ONE PER EACH MORCELLATOR SYSTEM. THE PRINCIPAL OUTCOME GOAL OF THE STUDY WAS THE MORCELLATION EFFICIENCY, AND ALSO INDWELLING CATHETER TIME, CONTINUOUS BLADDER IRRIGATION TIME, BLADDER INJURY RATE, DEVICE FAILURE RATE, INCIDENCE OF DIFFICULT CRUSHING AND SUCTION, AND INCIDENCE OF URINARY RETENTION CAUSED BY TISSUE RESIDUE. IN REGARDS OF THE RESULTS, THE MORCELLATION TIME AND RATE WERE SIMILAR WITH BOTH SYSTEMS WHEN THE PROSTATE VOLUME WAS UNDER OR EQUAL TO 60ML, BUT FOR PROSTATE VOLUME OVER 60 ML THE PIRANHA MORCELLATOR SHOWED A SHORTER MORCELLATION TIME AND A HIGHER MORCELLATION RATE. ADDITIONALLY, THE PIRANHA MORCELLATOR PRESENTED MORE MECHANICAL FAILURE RATE AND THE RATE OF DIFFICULTY IN MORCELLATION WAS HIGHER WITH VERSACUT SYSTEM, ALSO WITH BOTH SYSTEMS THE BLADDER MUCOSAL INJURY RATE ON PATIENTS WAS SIMILAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1225420 | VERSACUT | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | LUMENIS LTD | UNK-P-VERSACUT_MORCELLATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |