BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPULSE POWERSUITE

    MDR report key: 17914217 · Received October 11, 2023

    Report

    Report Number
    2124215-2023-56042
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    March 10, 2023
    Report Date
    November 17, 2023
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE LITERATURE ARTICLE [PREDICTION OF INFECTIVE COMPLICATIONS AFTER RETROGRADE INTRA RENAL SURGERY USING MACHINE LEARNING] INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES. MITHAT, E., ALI, E.F., ISMAIL, E., EMRE, S., YUSUF, A., TANER, K., AHMET, H., ABDULLAH, H. Y., SELCUK, S., ALI, I.T. (2023). PREDICTION OF INFECTIVE COMPLICATIONS AFTER RETROGRADE INTRA RENAL SURGERY USING MACHINE LEARNING. MINIMALLY INVASIVE THERAPY & ALLIED TECHNOLOGIES, VOLUME 32 (2), 73-80. DOI:10.1080/13645706.2023.2186181. B.3 DATE OF EVENT: DATE OF THE ARTICLE WAS USED. B.5 DESCRIBE EVENT OR PROBLEM: CORRECTION. E.1 INITIAL REPORTER FACILITY NAME: CORRECTION. 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 THE USE 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.

    Additional Manufacturer Narrative · 0

    MITHAT, E., ALI, E.F., ISMAIL, E., EMRE, S., YUSUF, A., TANER, K., AHMET, H., ABDULLAH, H. Y., SELCUK, S., ALI, I.T. (2023). PREDICTION OF INFECTIVE COMPLICATIONS AFTER RETROGRADE INTRA RENAL SURGERY USING MACHINE LEARNING. MINIMALLY INVASIVE THERAPY & ALLIED TECHNOLOGIES, VOLUME 32 (2), 73-80. DOI:10.1080/13645706.2023.2186181. B.3 DATE OF EVENT: DATE OF THE ARTICLE WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO COMPARE THE MODELS OBTAINED WITH CLASSICAL STATISTICAL METHODS AND MACHINE LEARNING (ML) ALGORITHMS TO PREDICT CATASTROPHIC INFECTIVE COMPLICATIONS (PICS, INCLUDING FEVER, SEPSIS, SEPTIC SHOCK) AFTER RETROGRADE INTRARENAL SURGERY (RIRS). THE DATA OF THE PATIENTS WERE RECORDED PROSPECTIVELY AND ANALYZED RETROSPECTIVELY. IN ADDITION TO CLINICAL DATA, SUCH AS AGE, GENDER, BODY MASS INDEX (BMI), ASA SCORE; STONE SIDE, PRESENCE OF EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) HISTORY AND THE NUMBER OF SESSIONS, PREVIOUS OPERATIONS ON THE SAME KIDNEY, NEED FOR A PREOPERATIVE STENT, HYDRONEPHROSIS (HUN) DEGREE, STONE DATA, SUCH AS LOCALIZATION, NUMBER, DENSITY, GUY S STONE SCORES AND STONE BURDEN WERE RECORDED. IN ADDITION, OPERATION TIME, HOSPITAL STAY, STONE-FREE STATUS (SFS), AND COMPLICATIONS WERE NOTED. ALL PATIENTS UNDERWENT PREOPERATIVE CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) TO EVALUATE THE FEATURES OF THE STONES AND THE URINARY SYSTEM. INTRAVENOUS PYELOGRAM (IVP) WAS APPLIED FOR CONTRAST- ENHANCED EXAMINATIONS IN PATIENTS WHO UNDERWENT NON-CONTRAST CT IN OTHER CLINICS PREVIOUSLY. THE POSITION OF THE RESIDUAL STONES AND THE URETERAL STENT WERE EVALUATED WITH KIDNEY-URETER-BLADDERGRAPHY ON THE FIRST POSTOPERATIVE DAY. STONE-FREE STATUS (SFS) WAS DEFINED AS THE ABSENCE OF STONES OR STONES GREATER THAN 2 MM IN THE CT SCAN PERFORMED ONE MONTH POSTOPERATIVELY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: THOSE WHO DEVELOPED PICS AFTER THE OPERATION AND THOSE WHO DID NOT. THE CRITERIA DETERMINED AT THE INTERNATIONAL SEPSIS DEFINITIONS CONFERENCE WERE USED FOR THE INFECTIVE DEFINITIONS. FEVER WAS DEFINED AS A RISE IN BODY TEMPERATURE GREATER THAN 38 DEGREES CELSIUS (C) AND PERSISTENCE FOR TWO DAYS OR BODY TEMPERATURE GREATER THAN 39 DEGREES C ON THE FIRST POSTOPERATIVE DAY. SEPSIS WAS DEFINED AS LIFE-THREATENING ORGAN DYSFUNCTION DUE TO A DYSREGULATED HOST RESPONSE TO INFECTION. SEPTIC SHOCK IS DEFINED AS A SUBSET OF SEPSIS IN WHICH PARTICULARLY PROFOUND CIRCULATORY, CELLULAR, AND METABOLIC ABNORMALITIES SUBSTANTIALLY INCREASE MORTALITY. COMPLICATIONS WERE CLASSIFIED ACCORDING TO THE MODIFIED CLAVIEN DINDO CLASSIFICATION. A TOTAL OF 322 PATIENTS WERE INCLUDED. 279 PATIENTS WHO DID NOT DEVELOP PICS WERE CLASSIFIED AS GROUP 1 (86.6 PERCENT), AND 43 PATIENTS WHO DID WERE CLASSIFIED AS GROUP 2 (13.3 PERCENT). THE MEAN AGE OF ALL PATIENTS WAS 45.3 PLUS OR MINUS 14.3 YEARS, AND THE MEAN BMI WAS CALCULATED AS 25.2 PLUS OR MINUS 2.3 KG/M2. THE AGE, GENDER, BMI, ASA SCORES, THE RATES OF HYPERTENSION WERE SIMILAR. OPERATIONS WERE PERFORMED BY ENDOUROLOGISTS EXPERIENCED IN RETROGRADE INTRARENAL SURGERY (RIRS). UNDER GENERAL ANESTHESIA AND IN THE LITHOTOMY POSITION, THE URETER WAS EVALUATED WITH A SEMI-RIGID URETEROSCOPE AND A GUIDEWIRE WAS PLACED IN THE RENAL PELVIS. STONES WERE FRAGMENTED WITH A 200MM HOLMIUM LASER (COHERENT POWER SUITE, 60 WATTS, LUMENIS, YOKNEAM, ISRAEL) UNTIL THEY WERE SMALL ENOUGH TO ALLOW FOR SPONTANEOUS REMOVAL, AND A NITINOL BASKET WAS USED TO COLLECT THE FRAGMENTS. LASER ENERGY AND PULSE FREQUENCY VARIED ACCORDING TO STONE CHARACTERISTICS. THE STONE CLEARANCE AND INTEGRITY OF THE COLLECTING SYSTEM WERE CHECKED WITH ENDOSCOPIC AND RETROGRADE PYELOGRAPHY. A URETERAL DOUBLE J (DJ) CATHETER WAS ROUTINELY PLACED AFTER THE SURGERY, AND ANY NEPHROSTOMY CATHETERS WERE REMOVED. THE URETERAL STENT WAS REMOVED IN PATIENTS WHO WERE DEEMED SUITABLE IN THE FIRST POSTOPERATIVE MONTH. COMPLICATIONS ACCORDING TO THE MODIFIED CLAVIEN DINDO GRADING SYSTEM WERE AS FOLLOW: 5.7 PERCENT OF PATIENTS IN GROUP 1 HAD MUCOSAL INJURY WHILE 9.3 PERCENT OF PATIENTS HAD MUCOSAL INJURY. 0.7 PERCENT OF GROUP 1 HAD URETERAL PERFORATION. 1.4 PERCENT OF GROUP 1 HAD RENAL COLIC WHILE GROUP 2 HAD 6.9 PERCENT OF IT. 79 PERCENT IN GROUP 2 HAD FEVER. 0.3 PERCENT OF GROUP 1 HAD URETERAL STRICTURE. 20.9 PERCENT OF GROUP 2 HAD SEPSIS. AFTER ANALYSIS OF THE DATA, THE STUDY CONCLUDED THAT WITH ML, MORE RELIABLE AND PREDICTIVE MODELS CAN BE CREATED THAN WITH CLASSICAL STATISTICAL METHODS. REFERENCE LITERATURE ARTICLE [PREDICTION OF INFECTIVE COMPLICATIONS AFTER RETROGRADE INTRA RENAL SURGERY USING MACHINE LEARNING] INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO COMPARE THE MODELS OBTAINED WITH CLASSICAL STATISTICAL METHODS AND MACHINE LEARNING (ML) ALGORITHMS TO PREDICT CATASTROPHIC INFECTIVE COMPLICATIONS (PICS, INCLUDING FEVER, SEPSIS, SEPTIC SHOCK) AFTER RETROGRADE INTRARENAL SURGERY (RIRS). THE DATA OF THE PATIENTS WERE RECORDED PROSPECTIVELY AND ANALYZED RETROSPECTIVELY. IN ADDITION TO CLINICAL DATA, SUCH AS AGE, GENDER, BODY MASS INDEX (BMI), ASA SCORE; STONE SIDE, PRESENCE OF EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) HISTORY AND THE NUMBER OF SESSIONS, PREVIOUS OPERATIONS ON THE SAME KIDNEY, NEED FOR A PREOPERATIVE STENT, HYDRONEPHROSIS (HUN) DEGREE, STONE DATA, SUCH AS LOCALIZATION, NUMBER, DENSITY, GUY S STONE SCORES AND STONE BURDEN WERE RECORDED. IN ADDITION, OPERATION TIME, HOSPITAL STAY, STONE-FREE STATUS (SFS), AND COMPLICATIONS WERE NOTED. ALL PATIENTS UNDERWENT PREOPERATIVE CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) TO EVALUATE THE FEATURES OF THE STONES AND THE URINARY SYSTEM. INTRAVENOUS PYELOGRAM (IVP) WAS APPLIED FOR CONTRAST- ENHANCED EXAMINATIONS IN PATIENTS WHO UNDERWENT NON-CONTRAST CT IN OTHER CLINICS PREVIOUSLY. THE POSITION OF THE RESIDUAL STONES AND THE URETERAL STENT WERE EVALUATED WITH KIDNEY-URETER-BLADDERGRAPHY ON THE FIRST POSTOPERATIVE DAY. STONE-FREE STATUS (SFS) WAS DEFINED AS THE ABSENCE OF STONES OR STONES GREATER THAN 2 MM IN THE CT SCAN PERFORMED ONE MONTH POSTOPERATIVELY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: THOSE WHO DEVELOPED PICS AFTER THE OPERATION AND THOSE WHO DID NOT. THE CRITERIA DETERMINED AT THE INTERNATIONAL SEPSIS DEFINITIONS CONFERENCE WERE USED FOR THE INFECTIVE DEFINITIONS. FEVER WAS DEFINED AS A RISE IN BODY TEMPERATURE GREATER THAN 38 DEGREES CELSIUS (C) AND PERSISTENCE FOR TWO DAYS OR BODY TEMPERATURE GREATER THAN 39 DEGREES C ON THE FIRST POSTOPERATIVE DAY. SEPSIS WAS DEFINED AS LIFE-THREATENING ORGAN DYSFUNCTION DUE TO A DYSREGULATED HOST RESPONSE TO INFECTION. SEPTIC SHOCK IS DEFINED AS A SUBSET OF SEPSIS IN WHICH PARTICULARLY PROFOUND CIRCULATORY, CELLULAR, AND METABOLIC ABNORMALITIES SUBSTANTIALLY INCREASE MORTALITY. COMPLICATIONS WERE CLASSIFIED ACCORDING TO THE MODIFIED CLAVIEN DINDO CLASSIFICATION. A TOTAL OF 322 PATIENTS WERE INCLUDED. 279 PATIENTS WHO DID NOT DEVELOP PICS WERE CLASSIFIED AS GROUP 1 (86.6 PERCENT), AND 43 PATIENTS WHO DID WERE CLASSIFIED AS GROUP 2 (13.3 PERCENT). THE MEAN AGE OF ALL PATIENTS WAS 45.3 PLUS OR MINUS 14.3 YEARS, AND THE MEAN BMI WAS CALCULATED AS 25.2 PLUS OR MINUS 2.3 KG/M2. THE AGE, GENDER, BMI, ASA SCORES, THE RATES OF HYPERTENSION WERE SIMILAR. OPERATIONS WERE PERFORMED BY ENDOUROLOGISTS EXPERIENCED IN RETROGRADE INTRARENAL SURGERY (RIRS). UNDER GENERAL ANESTHESIA AND IN THE LITHOTOMY POSITION, THE URETER WAS EVALUATED WITH A SEMI-RIGID URETEROSCOPE AND A GUIDEWIRE WAS PLACED IN THE RENAL PELVIS. STONES WERE FRAGMENTED WITH A 200MM HOLMIUM LASER (COHERENT POWER SUITE, 60 WATTS, LUMENIS, YOKNEAM, ISRAEL) UNTIL THEY WERE SMALL ENOUGH TO ALLOW FOR SPONTANEOUS REMOVAL, AND A NITINOL BASKET WAS USED TO COLLECT THE FRAGMENTS. LASER ENERGY AND PULSE FREQUENCY VARIED ACCORDING TO STONE CHARACTERISTICS. THE STONE CLEARANCE AND INTEGRITY OF THE COLLECTING SYSTEM WERE CHECKED WITH ENDOSCOPIC AND RETROGRADE PYELOGRAPHY. A URETERAL DOUBLE J (DJ) CATHETER WAS ROUTINELY PLACED AFTER THE SURGERY, AND ANY NEPHROSTOMY CATHETERS WERE REMOVED. THE URETERAL STENT WAS REMOVED IN PATIENTS WHO WERE DEEMED SUITABLE IN THE FIRST POSTOPERATIVE MONTH. COMPLICATIONS ACCORDING TO THE MODIFIED CLAVIEN DINDO GRADING SYSTEM WERE AS FOLLOW: 16 PERCENT OF PATIENTS IN GROUP 1 HAD MUCOSAL INJURY WHILE 4 PERCENT OF PATIENTS HAD MUCOSAL INJURY. 2 PERCENT OF GROUP 1 HAD URETERAL PERFORATION. 4 PERCENT OF GROUP 1 HAD RENAL COLIC WHILE GROUP 2 HAD 3 PERCENT OF IT. 34 PERCENT IN GROUP 2 HAD FEVER. 1 PERCENT OF GROUP 1 HAD URETERAL STRICTURE. 9 PERCENT OF GROUP 2 HAD SEPSIS. AFTER ANALYSIS OF THE DATA, THE STUDY CONCLUDED THAT WITH ML, MORE RELIABLE AND PREDICTIVE MODELS CAN BE CREATED THAN WITH CLASSICAL STATISTICAL METHODS. REFERENCE LITERATURE ARTICLE [PREDICTION OF INFECTIVE COMPLICATIONS AFTER RETROGRADE INTRA RENAL SURGERY USING MACHINE LEARNING] INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164199 VERSAPULSE POWERSUITE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-VPPS_SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Other COHERENT POWER SUITE, 60 WATTS, LUMENIS.| COHERENT POWER SUITE, 60 WATTS, LUMENIS.