MAUDE Adverse Event Report: LUMENIS LTD MOSES PULSE; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0006900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558); Unspecified Tissue Injury (4559)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Citation: friedrich, o., luisa, e., britta, g., christopher, n.(2024).Perioperative outcomes and complication rates in holmium laser enucleation of the prostate patients after prior prostate biopsy.Does it really make a difference? a propensity score matched analysis.Journal of endourology 2024 (38), 675 - 681.
Event or Problem Description
It was reported in the journal of endourology that a retrospective study was conducted to determine whether a short-term pb (prostate biopsy) before holep (holmium laser enucleation of the prostate) has an impact on the perioperative outcomes or complications of holep.A total of 734 patients who were treated by holep procedure were enrolled from january 2021 to july 2023.The following boston scientific products were used during the procedures: lumenis pulse 120h holmium-laser system.Intraoperatively, some patients experienced undermining bladder neck and perforations of the capsule.One patient required a reintervention, 60 patients experienced post-operative aur (acute urinary retention), 9 more patients required blood transfusion.The study confirmed that 87 patients presented prolonged macrohematuria; 57 patient developed urinary tract infection, and it was needed administration of antibiotics.Finally, the study confirmed 16 patients required endoscopic hemostasis under general anesthesia and 6 patients underwent a radiological catheter insertion.It is concluded that the pb less than 6 months before holep did not affect perioperative outcomes or complications.The necessity of pb should be carefully evaluated; however, holep can safely be performed following recent pb and therefore should not be delayed.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient effects of perforation, tissue damage, urinary retention, hematuria, infection-urinary tract are a known risk associated with implant of 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.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.Citation: friedrich, o., luisa, e., britta, g., christopher, n.(2024).Perioperative outcomes and complication rates in holmium laser enucleation of the prostate patients after prior prostate biopsy.Does it really make a difference? a propensity score matched analysis.Journal of endourology 2024 (38), 675 - 681.
Event or Problem Description
It was reported in the journal of endourology that a retrospective study was conducted to determine whether a short-term pb (prostate biopsy) before holep (holmium laser enucleation of the prostate) has an impact on the perioperative outcomes or complications of holep.A total of 734 patients who were treated by holep procedure were enrolled from january 2021 to july 2023.The following boston scientific products were used during the procedures: lumenis pulse 120h holmium-laser system.Intraoperatively, some patients experienced undermining bladder neck and perforations of the capsule.One patient required a reintervention, 60 patients experienced post-operative aur (acute urinary retention), 9 more patients required blood transfusion.The study confirmed that 87 patients presented prolonged macrohematuria; 57 patient developed urinary tract infection, and it was needed administration of antibiotics.Finally, the study confirmed 16 patients required endoscopic hemostasis under general anesthesia and 6 patients underwent a radiological catheter insertion.It is concluded that the pb less than 6 months before holep did not affect perioperative outcomes or complications.The necessity of pb should be carefully evaluated; however, holep can safely be performed following recent pb and therefore should not be delayed.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22091616
• Report Number: 2124215-2025-33924
• Device Sequence Number: 6935309
• Product Code: GEX
• UDI-Device Identifier: 07290109145402
• UDI-Public: (01)07290109145402
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: GA-0006900
• Device Catalogue Number: GA-0006900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown