BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACUT TISSUE MORCELLATOR

    MDR report key: 9334321 · Received November 18, 2019

    Report

    Report Number
    3004135191-2019-00127
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 18, 2019
    Report Date
    November 18, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEI
    UDI-DI
    07290109140681
    PMA / PMN Number
    K050639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY FOR ADDITIONAL INFORMATION. DESPITE REASONABLE ATTEMPTS, NO ADDITIONAL INFORMATION HAD BEEN PROVIDED OTHER THAN THE INITIAL REPORT AND INCIDENT FORM. A TWO YEAR HISTORICAL REVIEW OF SIMILAR COMPLAINTS REVEALED THAT THE SAME ISSUE OF MORCELLATOR' S BLADE TIPS BREAKING HAS NOT LED TO SERIOUS INJURY IN THE PAST. TO DATE LUMENIS IS UNAWARE OF SUCH EVENTS EVER HAVING OCCURRED; THIS REPRESENTS A SINGLE EVENT. A REVIEW OF SYSTEM RISK FILES ((B)(4)) REVEALED RISK #1.1.10; " CUTTING BLADES DAMAGED; BLADES DISTAL EDGE BREAKS AND "SINKS" ONTO BLADDER FLOOR." THE RISK HAS BEEN QUANTIFIED AND FOUND TO BE REMOTE, AND THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. LUMENIS HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. DESPITE THE BLADE BEING RETURNED TO THE MANUFACTURER FOR ANALYSIS, THE BLADE TIP WAS NOT RETURNED: LUMENIS IS UNABLE TO DETERMINE THE CAUSE OF THE BREAK WITH THE LIMITED INFORMATION AVAILABLE. HOWEVER, INVESTIGATION IS STILL ONGOING, SHOULD NEW INFORMATION BECOME AVAILABLE AND IF THERE WILL BE A SIGNIFICANT CHANGE, THEN LUMENIS WILL FILE A FOLLOW-UP MDR. LUMENIS WILL CONTINUE TO MONITOR THIS FAILURE MODE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP (DOC NO. (B)(4)) AND PER POST MARKETING SURVEILLANCE PROCEDURE (DOC NO. (B)(4)).

    Description of Event or Problem · 1

    A FOREIGN USER FACILITY REPORTED THAT ON (B)(6) 2019 DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED,"DURING THE MORCELLATION IT WAS NOTED THE PROCEDURE WAS NOT AS EFFECTIVE AS NORMAL. INVESTIGATION REVEALED THE TIP WAS MISSING FROM THE MORCELLATOR BLADE. THE TIP LOCATED AND REMOVED FROM THE PATIENT. DUE TO THE EXTENDED TIME THE PATIENT WAS UNDER THERE WAS INCREASED FLUID RETENTION." NO DIRECT COMPLICATIONS CAME FROM THE FAILURE OF THE BLADE, HOWEVER THE PATIENT WAS "BLUE-LIGHTED TO A HOSPITAL WITH ICU FACILITIES WHERE THE PATIENT WAS ADMINISTERED DRUGS TO EXPEL EXCESS FLUIDS". IT WAS FURTHER REPORTED THAT PATIENT HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134018 VERSACUT TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR AND ACCESSORIES GEI LUMENIS LTD. VERSACUT TISSUE MORCELLATOR 07290109140681

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR