BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPOKIT

    MDR report key: 1654775 · Received April 6, 2010

    Report

    Report Number
    3007064469-2010-00001
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 6, 2010
    Report Date
    March 7, 2010
    Manufacturer
    OSYRIS MEDICAL
    Product Code
    GEX
    PMA / PMN Number
    K073617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR IMPORTER HAS MADE HIS BEST EFFORT TO GET MORE INFO ABOUT THE PT AND ABOUT THE EVENT, BUT WITHOUT SUCCESS. SUMMARY OF EVAL MADE BY THE MFR: VISUAL EXAM WAS PERFORMED. THE LUER LOCK HEAD OF THE CANNULA HAS SEPARATED FROM THE METAL TUBE OF THE CANNULA. IT SEEMS THAT THE SOLDERING OF THE TUBE ON THE LUER LOCK BECAME LOOSE. FOR MORE INVESTIGATION, OUR SUPPLIER WAS INFORMED, THE DEFAULT DEVICE WAS SENT TO THIS SUPPLIER. SO FAR, THEIR REPORT HAS NOT YET BEEN RECEIVED. IF THERE IS ANY FURTHER RELEVANT INFO, A SUPPLEMENTAL MFR'S REPORT WILL BE FILED. THEY CHECKED ALREADY ALL OF THEIR QC INSPECTION DOCUMENTS FOR THIS SPECIFIC LOT, AND EVERYTHING SEEMED TO LOOK CORRECT. IN THE MEAN-TIME, THEY HAVE ADDED AN EXTRA PULL TEST TO VERIFY THE ATTACHMENTS STRENGTH. CONCLUSIONS OF OUR RISK ANALYSIS: EVEN IF THE MALFUNCTION WAS TO REOCCUR, IT IS OBVIOUS TO THE PHYSICIAN. IN THE WORST CASE, THE CONSEQUENCE FOR THE PT IS THE NECESSITY TO ENLARGE THE INCISION AT THE INSERTION POINT IN ORDER TO REMOVE THE TUBE FROM THE BODY. THE DEFECTIVE PRODUCT COULD NOT LEAD TO A SERIOUS INJURY. (B)(4). IT IS POSSIBLE THAT OUR DEVICE HAS BEEN REPROCESSED, ALTHOUGH IN OUR LABELING, WE INDICATE THAT: "AFTER USE, THE PRODUCT HAS TO BE CONSIDERED AS A POTENTIAL DANGEROUS BIOLOGICAL WASTE. IT MAY NOT BE RE-USED NOR RE-STERILIZED AGAIN IN ANY CASE."

    Description of Event or Problem · 1

    THE DR HAD COMPLETED A LASER LIPOLYSIS PROCEDURE BETWEEN 50-60KJ WHEN HE NOTICED THAT THE CANNULA WAS MISSING. THE 16G METAL TUBE OF THE CANNULA SEPARATED FROM THE LUER LOCK HEAD AND HAD TRAVELED INTO THE PT'S BODY. WHEN THE DR EXTRACTED THE FIBER, THE METAL TUBE PORTION OF THE CANNULA REMAINED IN THE PT. THE DR HAD TO MAKE AN INCISION AND UTILIZED OTHER SURGICAL INSTRUMENTS TO EXTRACT THE PIECE THAT REMAINED IN THE PT. THE PT REQUIRED SUTURES FOR THE INCISION THAT WAS MADE TO EXTRACT THE CANNULA, BUT NOT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPOKIT GEX OSYRIS MEDICAL OSYHAND LIPO DFEO-OS-00229

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention