BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACUT

    MDR report key: 19602252 · Received June 24, 2024

    Report

    Report Number
    2124215-2024-37365
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    May 1, 2012
    Report Date
    August 1, 2024
    Manufacturer
    LUMENIS LTD
    Product Code
    GCJ
    PMA / PMN Number
    K050639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED PERFORMANCE ALLEGATION IN THIS COMPLAINT HAS NOT BEEN CONFIRMED, AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. WITHOUT A RETURNED DEVICE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS OF PERFORATION, HEMORRHAGE, INFECTION, URINARY TRACT, FEVER, URINARY RETENTION, INCONTINENCE, URINARY, URETHRAL STENOSIS/STRICTURE AND STENOSIS, NON-VASCULAR ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. ACCORDING TO THIS INFORMATION, A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. TAKEUCHI Y, SAWADA Y, WATANABE S, NI-ITSU Y, SEKIDO N. AGE-SPECIFIC EFFECT OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE ON OVERACTIVE BLADDER IN MEN WITH BENIGN PROSTATIC HYPERPLASIA: AN INVESTIGATION USING AN OVERACTIVE BLADDER SYMPTOM SCORE. LOW URIN TRACT SYMPTOMS. 2023 MAR;15(2):38-49.

    Additional Manufacturer Narrative · 0

    TAKEUCHI Y, SAWADA Y, WATANABE S, NI-ITSU Y, SEKIDO N. AGE-SPECIFIC EFFECT OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE ON OVERACTIVE BLADDER IN MEN WITH BENIGN PROSTATIC HYPERPLASIA: AN INVESTIGATION USING AN OVERACTIVE BLADDER SYMPTOM SCORE. LOW URIN TRACT SYMPTOMS. 2023 MAR;15(2):38-49.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE THAT THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE AGE-SPECIFIC EFFECT OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) ON OVERACTIVE BLADDER (OAB). A TOTAL OF (B)(4) CONSECUTIVE PATIENTS WHO UNDERWENT HOLEP WERE INCLUDED. THEY WERE DIVIDED INTO THREE GROUPS: PATIENTS AGED LESS THAN 65 YEARS, BETWEEN 65 AND 74, AND 75 OR OLDER. THE OAB SYMPTOM SCORE AS WELL AS OTHER RELEVANT VARIABLES OF LOWER URINARY TRACT SYMPTOMS AND FUNCTION WERE ASSESSED BEFORE AND 1, 3, 6, AND 12 MONTHS AFTER SURGERY. AGE-SPECIFIC PREVALENCE OF OAB, THE PROPORTION OF RESOLUTION OF OAB, AND DE NOVO OAB WERE EVALUATED. THE MEAN AGE OF PATIENTS WAS 70.7 YEARS, AND THE MEAN TOTAL PROSTATE VOLUME WAS 75.8 ML. THE MEAN OAB SYMPTOM SCORES BEFORE SURGERY OF PATIENTS AGED LESS THAN 65 YEARS, BETWEEN 65 AND 74, AND 75 OR OLDER WERE 6.0, 5.2, AND 5.7, RESPECTIVELY. AT 12 MONTHS AFTER SURGERY, THE SCORES FOR THE RESPECTIVE GROUPS HAD SIGNIFICANTLY DECREASED TO 2.1, 2.5, AND 3.5. THE PREVALENCE OF OAB BASED ON THE SCORE IN THE RESPECTIVE GROUPS WAS (B)(4)) PREOPERATIVELY AND (B)(4) AT 12 MONTHS AFTER THE SURGERY (B)(4). OF THOSE WITH PREOPERATIVE OAB, (B)(4) OF THE RESPECTIVE GROUPS SHOWED RESOLUTION OF OAB AT 12 MONTHS POSTOPERATIVELY ((B)(4)). IN CANDIDATES FOR SURGICAL DEOBSTRUCTION OF BENIGN PROSTATIC HYPERPLASIA, HOLEP HAS POTENTIAL TO IMPROVE OAB SYMPTOMS REGARDLESS OF AGE. REGARDING THE REPORTED HARMS WITH THIS STUDY CAN BE MENTIONED CAPSULAR PERFORATION, URETHRAL INJURY, SPHINCTER INJURY, BLADDER MUCOSAL INJURY, POSTOPERATIVE HEMORRHAGE, FEBRILE URINARY TRACT INFECTION, URINARY RETENTION, TRANSIENT URINARY INCONTINENCE, URETHRAL STRICTURE, BLADDER NECK CONTRACTURE AND URINARY INCONTINENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE THAT THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE AGE-SPECIFIC EFFECT OF TRANSURETHRAL HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) ON OVERACTIVE BLADDER (OAB). A TOTAL OF 186 CONSECUTIVE PATIENTS WHO UNDERWENT HOLEP WERE INCLUDED. THEY WERE DIVIDED INTO THREE GROUPS: PATIENTS AGED LESS THAN 65 YEARS, BETWEEN 65 AND 74, AND 75 OR OLDER. THE OAB SYMPTOM SCORE AS WELL AS OTHER RELEVANT VARIABLES OF LOWER URINARY TRACT SYMPTOMS AND FUNCTION WERE ASSESSED BEFORE AND 1, 3, 6, AND 12 MONTHS AFTER SURGERY. AGE-SPECIFIC PREVALENCE OF OAB, THE PROPORTION OF RESOLUTION OF OAB, AND DE NOVO OAB WERE EVALUATED. THE MEAN AGE OF PATIENTS WAS 70.7 YEARS, AND THE MEAN TOTAL PROSTATE VOLUME WAS 75.8 ML. THE MEAN OAB SYMPTOM SCORES BEFORE SURGERY OF PATIENTS AGED LESS THAN 65 YEARS, BETWEEN 65 AND 74, AND 75 OR OLDER WERE 6.0, 5.2, AND 5.7, RESPECTIVELY. AT 12 MONTHS AFTER SURGERY, THE SCORES FOR THE RESPECTIVE GROUPS HAD SIGNIFICANTLY DECREASED TO 2.1, 2.5, AND 3.5. THE PREVALENCE OF OAB BASED ON THE SCORE IN THE RESPECTIVE GROUPS WAS 45.8%, 56.9%, AND 54.0% (P = .6391) PREOPERATIVELY AND 9.1%, 11.3%, AND 15.8% AT 12 MONTHS AFTER THE SURGERY (P = .7613). OF THOSE WITH PREOPERATIVE OAB, 75.0%, 79.2%, AND 75.0% OF THE RESPECTIVE GROUPS SHOWED RESOLUTION OF OAB AT 12 MONTHS POSTOPERATIVELY (P = .9427). IN CANDIDATES FOR SURGICAL DEOBSTRUCTION OF BENIGN PROSTATIC HYPERPLASIA, HOLEP HAS POTENTIAL TO IMPROVE OAB SYMPTOMS REGARDLESS OF AGE. REGARDING THE REPORTED HARMS WITH THIS STUDY CAN BE MENTIONED CAPSULAR PERFORATION, URETHRAL INJURY, SPHINCTER INJURY, BLADDER MUCOSAL INJURY, POSTOPERATIVE HEMORRHAGE, FEBRILE URINARY TRACT INFECTION, URINARY RETENTION, TRANSIENT URINARY INCONTINENCE, URETHRAL STRICTURE, BLADDER NECK CONTRACTURE AND URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157335 VERSACUT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ LUMENIS LTD UNK-P-VERSACUT_MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other