BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACUT+ TISSUE MORCELLATOR

    MDR report key: 6278634 · Received January 26, 2017

    Report

    Report Number
    1720381-2017-00004
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    October 17, 2016
    Report Date
    January 27, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE REPORT FROM THE PATIENT, LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITIES' PHYSICIAN DIRECTLY, TO REQUEST PATIENT INFORMATION AND CLINICAL NOTES OF THE PROCEDURE. NO INFORMATION HAS BEEN PROVIDED BY THE TREATING PHYSICIAN AFTER FOUR REQUESTS. LUMENIS CONTINUES TO SEEK ADDITIONAL INFORMATION FROM THE PHYSICIAN. AN EXAMINATION OF THE VERSACUT+ TISSUE MORCELLATOR CONTROLLER BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT THE CONTROL UNIT OPERATED TO MANUFACTURER SPECIFICATIONS. THE HANDPIECE WAS RETURNED TO THE LOCAL LUMENIS OFFICE, WHICH HAS, SUBSEQUENTLY, BEEN SENT TO THE MANUFACTURING SITE IN ISRAEL FOR TESTING OF INTERNAL SPECIFICATIONS AND ANALYSIS. THE DEVICE IS CURRENTLY IN TRANSIT AND WILL BE EVALUATED UPON RECEIPT. LUMENIS INITIATED A RECALL FOR THE VERSACUT+ TISSUE MORCELLATOR HANDPIECES ON JULY 30, 2015. (REF# 3004135191-07/30/15-003-R). A REVIEW OF THE ORIGINAL CONSIGNEE LIST NOTED THAT THE USER FACILITY WAS INCLUDED ON THE CONSIGNEE LIST AND RECEIVED THE NOTIFICATION. THE CUSTOMER RETURNED TWO HANDPIECES FOLLOWING RECEIPT OF THE RECALL NOTIFICATION. THIS EVENT INVOLVED A HANDPIECE THAT WAS SUBJECT TO THE RECALL, BUT WAS NOT RETURNED BY THE CUSTOMER WHEN ITS OTHER TWO HANDPIECES WERE RETURNED TO LUMENIS. AS NOTED ABOVE, THE THIRD HANDPIECE THAT WAS INVOLVED IN THIS EVENT IS IN ROUTE TO LUMENIS, LTD. IN ISRAEL FOR RETURNED PRODUCT ANALYSIS (RPA). OUR RECORDS INDICATE THAT THE USER FACILITY HAS CONFIRMED THAT NO ADDITIONAL HANDPIECES ARE IN THEIR POSSESSION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED LUMENIS DIRECTLY TO REPORT THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE PHYSICIAN EXPERIENCED A FUNCTIONAL ISSUE WITH THE OPERATIONAL PERFORMANCE OF THE HANDPIECE. AS A RESULT, THE SURGEON HAD TO STOP THE PROCEDURE AFTER 2+ HOURS AND CONVERT THE PROCEDURE TO OPEN SURGERY. THE PATIENT STATED THE PROCEDURE TOOK OVER 4+ HOURS TO COMPLETE, HE REMAINED IN HOSPITAL AN ADDITIONAL NIGHT, HE HAD TO HAVE A CATHETER FOR THREE (3) EXTRA DAYS, AND HAD AN INCISION AND STITCHES THAT WERE REPORTED TO BE PAINFUL. THE PATIENT WAS UNABLE TO PROVIDE CONFIRMATION THAT THE DEVICE USED DURING HIS PROCEDURE WAS THE LUMENIS VERSACUT+ TISSUE MORCELLATOR HANDPIECE. THUS, LUMENIS COULD NOT VERIFY THAT THE EVENT WAS ASSOCIATED WITH A DEVICE IT MANUFACTURERS. ON DECEMBER 15, 2016, LUMENIS RECEIVED INFORMATION VIA SERVICE REGARDING A SERVICE REQUEST FOR A VERSACUT+ TISSUE MORCELLATOR UNIT. FOLLOW-UP WITH THE CUSTOMER PROVIDED ADDITIONAL INFORMATION THAT APPEARED TO BE RELATED TO THE ABOVE EVENT REPORTED BY THE PATIENT. THE CUSTOMER WAS ABLE TO CONFIRM THAT THE VERSACUT+ TISSUE MORCELLATOR WAS USED IN THIS PATIENT'S PROCEDURE. UPON CONFIRMATION THAT THE EVENT INVOLVED THE LUMENIS VERSACUT+ TISSUE MORCELLATOR HANDPIECE, THE COMPANY WAS ABLE TO CONCLUDE THAT THE EVENT WAS RELATED TO A PRODUCT IT MARKETS AND REFERRED THE EVENT FOR MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62568 VERSACUT+ TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR AND ACCESSORIES GEI LUMENIS, LTD. VERSAPULSE POWERSUITE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R