MOSES PULSE
Report
- Report Number
- 2124215-2025-37190
- Event Type
- Injury
- Date Received
- June 7, 2025
- Date of Event
- November 8, 2024
- Report Date
- October 14, 2025
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K170121
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MICHAEL, J., XU, P., DEAN, N., GANESH, M., TSAI, K., KHONDAKAR, N., RAIKAR, A., KRAMBECK, A. (2024). "CURRENT ERA HOLEP WITH MOSES 2.0 TECHNOLOGY COMPARED TO THE GOLD STANDARD TURP". WORLD JOURNAL OF UROLOGY 42, 633. HTTPS://DOI.ORG/10.1007/S00345-024-05309-2. 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 THIS DEVICE TYPE 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. MICHAEL, J., XU, P., DEAN, N., GANESH, M., TSAI, K., KHONDAKAR, N., RAIKAR, A., KRAMBECK, A. (2024). "CURRENT ERA HOLEP WITH MOSES 2.0 TECHNOLOGY COMPARED TO THE GOLD STANDARD TURP". WORLD JOURNAL OF UROLOGY 42, 633. HTTPS://DOI.ORG/10.1007/S00345-024-05309-2. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A RETROSPECTIVE REVIEW WAS CONDUCTED OF PATIENTS UNDERGOING BIPOLAR TURP( BTURP) OR HOLEP WITH MOSES 2.0 TECHNOLOGY (MOLEP). THE PURPOSE WAS TO EVALUATE AND COMPARE THE EFFICIENCY, EFFICACY, AND SAFETY OF CURRENT ERA MOLEP AND BTURP. THE STUDY ENCOMPASSED 195 BTURPS AND 918 MOLEPS PERFORMED AT A SINGLE INSTITUTION FROM 2018 TO 2023. MOLEP PROCEDURES WERE PERFORMED EXCLUSIVELY BY A SINGLE SURGERY (AK) WITH LASER SETTINGS 2 J AND 50 HZ FOR ENUCLEATION AND 2 J AND 20 HZ FOR HEMOSTASIS WITH MOSES 2.0 ENABLED IN SETTINGS USING A BILOBAR OR TRILOBAR TECHNIQUE. IT WAS NOTED THAT ALL MOLEP PROCEDURES WERE PERFORMED BY ONE HIGHLY EXPERIENCED SURGEON, AND THE MEAN FOLLOW-UP WAS 3.7 MONTHS. THE FOLLOWING 90 DAY COMPLICATIONS WERE REPORTED FOR THE MOLEP PROCEDURES: 95 PATIENTS HAD FAILED TRIAL OF VOID (TOV)/HEMATURIA/RETENTION WHICH WAS TREATED WITH INSERTION OF FOLEY, 38 PATIENTS HAD LOWER URINARY TRACT INFECTION WHICH WAS TREATED WITH ANTIBIOTICS, 15 PATIENTS HAD EMERGENCY DEPARTMENT (ED) VISIT FOR PAIN WHICH WAS TREATED WITH ANALGESICS, 6 PATIENTS HAD OTHER VARIOUS COMPLICATIONS (TONGUE LACERATION FROM ENDOTRACHEAL TUBE, FOOT DROP FROM POSITIONING, ILEUS, PRESYNCOPE POST-OP, ACUTE KIDNEY INJURY, HEART FAILURE EXACERBATION, THROMBOPHLEBITIS) WHICH WERE TREATED WITH PHYSICAL THERAPY AND OBSERVATION, 5 PATIENTS HAD URINARY TRACT INFECTION WITH SEPSIS WHICH WAS TREATED WITH ANTIBIOTICS, 2 PATIENTS HAD DEEP VEIN THROMBOSIS (DVT) WHICH WAS TREATED WITH ANTICOAGULATION, 2 PATIENTS HAD ACUTE BLOOD LOSS ANEMIA WHICH WAS TREATED WITH TRANSFUSION, 6 PATIENTS HAD CLOT RETENTION WHICH WAS TREATED WITH OPERATING ROOM (OR) CLOT EVACUATION, 2 PATIENTS HAD STROKE WHICH WERE TREATED WITH ANTICOAGULATION, AND 2 PATIENTS DIED DUE TO CARDIAC ARREST (ONE OCCURRED INPATIENT ON POSTOP DAY TWO AND THE OTHER ON POSTOP DAY TWELVE AT HOME). IT WAS NOTED THAT THE TWO PATIENTS PASSED AWAY FOLLOWING THE PROCEDURES, HOWEVER, BOTH DEATHS WERE DUE TO UNDERLYING CARDIAC DISEASE AND WERE NOT DUE TO THE DEVICE OR PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A RETROSPECTIVE REVIEW WAS CONDUCTED OF PATIENTS UNDERGOING BIPOLAR TURP( BTURP) OR HOLEP WITH MOSES 2.0 TECHNOLOGY (MOLEP). THE PURPOSE WAS TO EVALUATE AND COMPARE THE EFFICIENCY, EFFICACY, AND SAFETY OF CURRENT ERA MOLEP AND BTURP. THE STUDY ENCOMPASSED 195 BTURPS AND 918 MOLEPS PERFORMED AT A SINGLE INSTITUTION FROM 2018 TO 2023. MOLEP PROCEDURES WERE PERFORMED EXCLUSIVELY BY A SINGLE SURGERY (AK) WITH LASER SETTINGS 2 J AND 50 HZ FOR ENUCLEATION AND 2 J AND 20 HZ FOR HEMOSTASIS WITH MOSES 2.0 ENABLED IN SETTINGS USING A BILOBAR OR TRILOBAR TECHNIQUE. IT WAS NOTED THAT ALL MOLEP PROCEDURES WERE PERFORMED BY ONE HIGHLY EXPERIENCED SURGEON, AND THE MEAN FOLLOW-UP WAS 3.7 MONTHS. THE FOLLOWING 90 DAY COMPLICATIONS WERE REPORTED FOR THE MOLEP PROCEDURES: 95 PATIENTS HAD FAILED TRIAL OF VOID (TOV)/HEMATURIA/RETENTION WHICH WAS TREATED WITH INSERTION OF FOLEY, 38 PATIENTS HAD LOWER URINARY TRACT INFECTION WHICH WAS TREATED WITH ANTIBIOTICS, 15 PATIENTS HAD EMERGENCY DEPARTMENT (ED) VISIT FOR PAIN WHICH WAS TREATED WITH ANALGESICS, 6 PATIENTS HAD OTHER VARIOUS COMPLICATIONS (TONGUE LACERATION FROM ENDOTRACHEAL TUBE, FOOT DROP FROM POSITIONING, ILEUS, PRESYNCOPE POST-OP, ACUTE KIDNEY INJURY, HEART FAILURE EXACERBATION, THROMBOPHLEBITIS) WHICH WERE TREATED WITH PHYSICAL THERAPY AND OBSERVATION, 5 PATIENTS HAD URINARY TRACT INFECTION WITH SEPSIS WHICH WAS TREATED WITH ANTIBIOTICS, 2 PATIENTS HAD DEEP VEIN THROMBOSIS (DVT) WHICH WAS TREATED WITH ANTICOAGULATION, 2 PATIENTS HAD ACUTE BLOOD LOSS ANEMIA WHICH WAS TREATED WITH TRANSFUSION, 6 PATIENTS HAD CLOT RETENTION WHICH WAS TREATED WITH OPERATING ROOM (OR) CLOT EVACUATION, 2 PATIENTS HAD STROKE WHICH WERE TREATED WITH ANTICOAGULATION, AND 2 PATIENTS DIED DUE TO CARDIAC ARREST (ONE OCCURRED INPATIENT ON POSTOP DAY TWO AND THE OTHER ON POSTOP DAY TWELVE AT HOME). IT WAS NOTED THAT THE TWO PATIENTS PASSED AWAY FOLLOWING THE PROCEDURES, HOWEVER, BOTH DEATHS WERE DUE TO UNDERLYING CARDIAC DISEASE AND WERE NOT DUE TO THE DEVICE OR PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603494 | MOSES PULSE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-P120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |