BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACUT TISSUE MORCELLATOR

    MDR report key: 9669700 · Received February 5, 2020

    Report

    Report Number
    3004135191-2020-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 5, 2020
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEI
    UDI-DI
    07290109140681
    PMA / PMN Number
    K050639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY FOR ADDITIONAL INFORMATION. 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. A REVIEW OF SUBJECT DEVICE LUMENIS VERSACUT MORCELLATOR SYSTEM LABELING (0631-060-01_K) REVEALED THE FOLLOWING: "BLADE SETS HAVE A LIMITED REUSE OF APPROXIMATELY 2-8 TIMES, DEPENDING UPON THE SIZE AND CONSISTENCY OF THE TISSUE MORCELLATED". THE USER FACILITY MENTIONED THAT THEY DO NOT MONITOR THE NUMBER OF REPROCESSING THEY PERFORM, THUS THIS CAN BE THE CAUSE OF THE FAILURE. A REVIEW OF SYSTEM RISK FILES (0635-682-01 REV J) REVEALED RISK #1.1.10; " CUTTING BLADES DAMAGED; BLADES DISTAL EDGE BREAKS AND "SINKS" ONTO BLADDER FLOOR." THE RISK LIKELIHOOD HAS BEEN QUANTIFIED AND FOUND TO BE REMOTE, AND THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. IN THIS CASE, THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS TO THE PATIENT. ALTHOUGH THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION, IT IS UNCERTAIN IF THE USER FACILITY HAD TO USE THE ALTERNATE METHOD AS INTERVENTION TO PREVENT PERMANENT DAMAGE. IN AN ABUNDANCE OF CAUTION, LUMENIS IS REPORTING THIS MALFUNCTION. THE BLADE IS EXPECTED TO BE RETURNED TO LUMENIS FOR PRODUCT INVESTIGATION, 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 USER FACILITY REPORTED THAT AFTER A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED, THE PHYSICIAN REMOVED THE BLADE OF THE MORCELLATOR AND FOUND THAT THE TIP WAS MISSING FROM THE MORCELLATOR BLADE. AN X-RAY REVEALED THAT THE METAL PIECES WERE IN THE PATIENT'S BLADDER AND THE PHYSICIAN WAS ABLE TO RETRIEVE THE PIECES. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136953 VERSACUT TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR AND ACCESSORIES GEI LUMENIS LTD. VERSACUT TISSUE MORCELLATOR 07290109140681

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR