BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSES PULSE

    MDR report key: 17954286 · Received October 17, 2023

    Report

    Report Number
    2124215-2023-57464
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    October 1, 2018
    Report Date
    December 28, 2023
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GUY VERHOVSKY, YISHAI H. RAPPAPORT, DORIT E. ZILBERMAN, AMOSNEHEMAN, AMNONZISMAN, ILAN GIELCHINSKY, LEON CHERTIN AND ITAY M. SABLER. TUBELESS URETERORENOSCOPY-OUR EXPERIENCE USING A 120 W LASER AND DUSTING TECHNIQUE: POSTOPERATIVE PAIN, COMPLICATIONS, AND READMISSIONS. JOURNAL OF PERSONALIZED MEDICINE PUBLISHED ON NOV 9, 2022. HTTPS://DOI.ORG/10.3390/JPM12111878.

    Additional Manufacturer Narrative · 0

    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. GUY VERHOVSKY, YISHAI H. RAPPAPORT, DORIT E. ZILBERMAN, AMOSNEHEMAN, AMNONZISMAN, ILAN GIELCHINSKY, LEON CHERTIN AND ITAY M. SABLER. TUBELESS URETERORENOSCOPY-OUR EXPERIENCE USING A 120 W LASER AND DUSTING TECHNIQUE: POSTOPERATIVE PAIN, COMPLICATIONS, AND READMISSIONS. JOURNAL OF PERSONALIZED MEDICINE PUBLISHED ON NOV 9, 2022. HTTPS://DOI.ORG/10.3390/JPM12111878.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF PERSONALIZED MEDICINE A RETROSPECTIVE STUDY UTILIZING MOSES PULSE 120 HOLMIUM LASER CONSOLE. THE STUDY EVALUATED THREE DRAINAGE SUBGROUPS AND COMPARED POSTOPERATIVE PAIN, COMPLICATIONS, AND READMISSIONS. A DATABASE REVIEW WAS CONDUCTED OF 269 CONSECUTIVE PATIENTS WHO UNDERWENT PRIMARY URETERORENOSCOPY FOR THE TREATMENT OF UPPER URINARY TRACT STONES BETWEEN OCTOBER 2018 AND AUGUST 2019. THE COHORT WAS DIVIDED ACCORDING TO POST-OPERATIVE DRAINAGE AS TUBELESS, URETER CATHETER (UC), AND DOUBLE J-STENT (DJS) AND THEIR RELATION TO POSTOPERATIVE COMPLICATIONS (FEVER, ACUTE RENAL FAILURE, AND THE OBSTRUCTION OF THE UPPER URINARY TRACT BY STONE STREET) WERE ASSESSED. OF THE 269 PATIENTS 136 (50%) WERE DRAINED WITH UC, 63 (24%) WERE DRAINED WITH DJS AND 70 (26%) WERE TUBELESS. IN THE TUBELESS GROUP 7 PATIENTS HAD RENAL COLIC AND 1 PATIENT HAD ACUTE RENAL FAILURE. IN THE STENT GROUP 4 PATIENTS HAD RENAL COLIC, 1 PATIENT HAD ACUTE RENAL FAILURE, AND 7 PATIENTS HAD SEPSIS/FEVER. IN THE UC GROUP 27 PATIENTS HAD RENAL COLIC, 5 PATIENTS HAD ACUTE RENAL FAILURE, AND 13 PATIENTS HAD SEPSIS/FEVER. AUXILIARY PROCEDURES WERE MORE PREVALENT IN THE STENTED GROUP, BUT THE OVERALL STONE-FREE RATE WAS NOT SIGNIFICANTLY DIFFERENT. POSTOPERATIVE ER VISITS, READMISSIONS, AND COMPLICATIONS WERE THE HIGHEST IN THE UC-DRAINED GROUP, AT 20% IN THE UC VS. 6% IN THE TUBELESS AND 10% IN THE STENTED GROUPS. POST-OPERATIVE PAIN LEVELS AND ANALGESIC USE WERE SIGNIFICANTLY LOWER IN THE TUBELESS GROUP WITH A SIGNIFICANT REDUCTION IN OPIATE USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF PERSONALIZED MEDICINE A RETROSPECTIVE STUDY UTILIZING MOSES PULSE 120 HOLMIUM LASER CONSOLE. THE STUDY EVALUATED THREE DRAINAGE SUBGROUPS AND COMPARED POSTOPERATIVE PAIN, COMPLICATIONS, AND READMISSIONS. A DATABASE REVIEW WAS CONDUCTED OF 269 CONSECUTIVE PATIENTS WHO UNDERWENT PRIMARY URETERORENOSCOPY FOR THE TREATMENT OF UPPER URINARY TRACT STONES BETWEEN OCTOBER 2018 AND AUGUST 2019. THE COHORT WAS DIVIDED ACCORDING TO POST-OPERATIVE DRAINAGE AS TUBELESS, URETER CATHETER (UC), AND DOUBLE J-STENT (DJS) AND THEIR RELATION TO POSTOPERATIVE COMPLICATIONS (FEVER, ACUTE RENAL FAILURE, AND THE OBSTRUCTION OF THE UPPER URINARY TRACT BY STONE STREET) WERE ASSESSED. OF THE 269 PATIENTS 136 (50%) WERE DRAINED WITH UC, 63 (24%) WERE DRAINED WITH DJS AND 70 (26%) WERE TUBELESS. IN THE TUBELESS GROUP 7 PATIENTS HAD RENAL COLIC AND 1 PATIENT HAD ACUTE RENAL FAILURE. IN THE STENT GROUP 4 PATIENTS HAD RENAL COLIC, 1 PATIENT HAD ACUTE RENAL FAILURE, AND 7 PATIENTS HAD SEPSIS/FEVER. IN THE UC GROUP 27 PATIENTS HAD RENAL COLIC, 5 PATIENTS HAD ACUTE RENAL FAILURE, AND 13 PATIENTS HAD SEPSIS/FEVER. AUXILIARY PROCEDURES WERE MORE PREVALENT IN THE STENTED GROUP, BUT THE OVERALL STONE-FREE RATE WAS NOT SIGNIFICANTLY DIFFERENT. POSTOPERATIVE ER VISITS, READMISSIONS, AND COMPLICATIONS WERE THE HIGHEST IN THE UC-DRAINED GROUP, AT 20% IN THE UC VS. 6% IN THE TUBELESS AND 10% IN THE STENTED GROUPS. POST-OPERATIVE PAIN LEVELS AND ANALGESIC USE WERE SIGNIFICANTLY LOWER IN THE TUBELESS GROUP WITH A SIGNIFICANT REDUCTION IN OPIATE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97255 MOSES PULSE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-P120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R