BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACUT

    MDR report key: 17907796 · Received October 10, 2023

    Report

    Report Number
    2124215-2023-56075
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    January 1, 2014
    Report Date
    December 22, 2023
    Manufacturer
    LUMENIS LTD
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 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. DAE HYUN KIM, CHANG SUK KANG, JAE WHI CHOI, SEONG UK JEH, SEE MIN CHOI, CHUN WOO LEE, SUNG CHUL KAM, JEONG SEOK HWA, AND JAE SEOG HYUN. THE EFFICACY AND SAFETY OF 'INVERTED OMEGA EN-BLOC' HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) FOR BENIGN PROSTATIC HYPERPLASIA: A SIZE-INDEPENDENT TECHNIQUE FOR THE SURGICAL TREATMENT OF LUTS. WORLD J MENS HEALTH PUBLISHED ONLINE APR 3, 2023. HTTPS://DOI.ORG/10.5534/WJMH.220225.

    Additional Manufacturer Narrative · 0

    DAE HYUN KIM, CHANG SUK KANG, JAE WHI CHOI, SEONG UK JEH, SEE MIN CHOI, CHUN WOO LEE, SUNG CHUL KAM, JEONG SEOK HWA, AND JAE SEOG HYUN. THE EFFICACY AND SAFETY OF 'INVERTED OMEGA EN-BLOC' HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) FOR BENIGN PROSTATIC HYPERPLASIA: A SIZE-INDEPENDENT TECHNIQUE FOR THE SURGICAL TREATMENT OF LUTS. WORLD J MENS HEALTH PUBLISHED ONLINE APR 3, 2023. HTTPS://DOI.ORG/10.5534/WJMH.220225

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF MEN'S HEALTH THAT A RETROSPECTIVE REVIEW WAS CONDUCTED OF THE PATIENTS WHO HAD UNDERGONE AN INVERTED OMENT EN-BLOC HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) TO EVALUATE THE SAFETY AND EFFICACY OF THIS METHOD FOR THE TREATMENT OF BENIGN PROSTATE HYPERPLASIA (BPH) WITH LOWER URINARY TRACT SYMPTOMS (LUTS). THE MEDICAL RECORDS OF 716 PATIENTS WHO UNDERWENT INVERTED OMEGA EN-BLOC HOLEP BETWEEN 2014 AND 2021 WERE REVIEWED. ALL PROCEDURES WERE PERFORMED BY A SINGLE SURGEON AND WERE FORMED USING A 100W HOLMIUM:YTTRIUM-ALUMINUM-GARNET LASER SYSTEM WITH A 550 MICRON END-FIRING LASER FIBER AND A VERSCUT TISSUE MORCELLATOR. THERE WERE NO MAJOR LIFE-THREATENING COMPLICATIONS THAT OCCURRED DURING THE PROCEDURES. FOLLOWING THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED: 11 PATIENTS HAD URETHRAL STRICTURE, 12 PATIENTS HAD BLADDER NECK CONTRACTURE, 14 PATIENTS HAD URINARY INCONTINENCE, AND 4 PATIENTS EXPERIENCED BLADDER INJURIES FROM THE MORCELLATOR. THE FOLLOWING PROCEDURES WERE DONE TO SURGICALLY MANAGE THE COMPLICATIONS REPORTED: 9 PATIENTS UNDERWENT URETHRAL SOUNDING, 2 PATIENTS UNDERWENT ENDOSCOPIC INTERNAL URETHROTOMY, 12 PATIENTS UNDERWENT AN ADDITIONAL HOLEP PROCEDURE TO TREAT THE BLADDER NECK CONTRACTURES, AND 15 PATIENTS UNDERWENT AN ADDITIONAL HOLEP PROCEDURE TO TREAT REGROWING ADENOMAS. ADDITIONALLY, THE FOLLOWING POSTOPERATIVE MEDICALS EXCEEDING SIX MONTHS WERE: 22 PATIENTS REQUIRED ALPHA BLOCKERS, 16 PATIENTS REQUIRED CHOLINERGICS, 58 PATIENTS REQUIRED ANTICHOLINERGICS OR BETA-3 AGONISTS, 18 PATIENTS REQUIRED ANTIDIURETICS, AND 38 PATIENTS REQUIRED DAILY PDE-5 INHIBITORS. THIS EVENT IS FOR THE VERSACUT MORCELLATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF MEN'S HEALTH THAT A RETROSPECTIVE REVIEW WAS CONDUCTED OF THE PATIENTS WHO HAD UNDERGONE AN INVERTED OMENT EN-BLOC HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) TO EVALUATE THE SAFETY AND EFFICACY OF THIS METHOD FOR THE TREATMENT OF BENIGN PROSTATE HYPERPLASIA (BPH) WITH LOWER URINARY TRACT SYMPTOMS (LUTS). THE MEDICAL RECORDS OF 716 PATIENTS WHO UNDERWENT INVERTED OMEGA EN-BLOC HOLEP BETWEEN 2014 AND 2021 WERE REVIEWED. ALL PROCEDURES WERE PERFORMED BY A SINGLE SURGEON AND WERE FORMED USING A 100W HOLMIUM:YTTRIUM-ALUMINUM-GARNET LASER SYSTEM WITH A 550 MICRON END-FIRING LASER FIBER AND A VERSCUT TISSUE MORCELLATOR. THERE WERE NO MAJOR LIFE-THREATENING COMPLICATIONS THAT OCCURRED DURING THE PROCEDURES. FOLLOWING THE PROCEDURES, THE FOLLOWING COMPLICATIONS WERE REPORTED: 11 PATIENTS HAD URETHRAL STRICTURE, 12 PATIENTS HAD BLADDER NECK CONTRACTURE, 14 PATIENTS HAD URINARY INCONTINENCE, AND 4 PATIENTS EXPERIENCED BLADDER INJURIES FROM THE MORCELLATOR. THE FOLLOWING PROCEDURES WERE DONE TO SURGICALLY MANAGE THE COMPLICATIONS REPORTED: 9 PATIENTS UNDERWENT URETHRAL SOUNDING, 2 PATIENTS UNDERWENT ENDOSCOPIC INTERNAL URETHROTOMY, 12 PATIENTS UNDERWENT AN ADDITIONAL HOLEP PROCEDURE TO TREAT THE BLADDER NECK CONTRACTURES, AND 15 PATIENTS UNDERWENT AN ADDITIONAL HOLEP PROCEDURE TO TREAT REGROWING ADENOMAS. ADDITIONALLY, THE FOLLOWING POSTOPERATIVE MEDICALS EXCEEDING SIX MONTHS WERE: 22 PATIENTS REQUIRED ALPHA BLOCKERS, 16 PATIENTS REQUIRED CHOLINERGICS, 58 PATIENTS REQUIRED ANTICHOLOINERGICS OR BETA-3 AGONISTS, 18 PATIENTS REQUIRED ANTIDIURETICS, AND 38 PATIENTS REQUIRED DAILY PDE-5 INHIBITORS. THIS EVENT IS FOR THE VERSACUT MORECELLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345768 VERSACUT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ LUMENIS LTD UNK-P-VERSACUT_MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R