BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE LAPFLEX HANDPIECE

    MDR report key: 4739633 · Received April 28, 2015

    Report

    Report Number
    3005350457-2015-00001
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 28, 2015
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K140378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS PROVIDED FROM THE SURGEON THAT WHILE THE CAUSE OF THE ABSCESS WAS UNK, HE CONCLUDED THAT IT WAS MOST LIKELY THE COMPLEXITY OF THE PROCEDURE, MAGNITUDE OF THE DISSECTION AND AMOUNT OF TISSUE DISRUPTED/REMOVED. THE PT WAS TREATED AND IS DOING FINE. THIS HANDPIECE WAS USED IN ADD'L CASES AFTER THIS EVENT, PRIOR TO BEING RETURNED TO OMNIGUIDE FOR EVAL. NO ADD'L ISSUES WERE REPORTED. THE HANDPIECE WAS RETURNED AND EVALUATED. IT WAS FOUND THAT THE DISTAL END OF THE HANDPIECE SHOWED SIGNS OF BLUNT FORCE (CONSISTENT WITH DROPPING), WHICH WAS NOT LIKELY TO HAVE CAUSED THE ADVERSE EVENT. THE DAMAGE STILL ALLOWED THE DEVICE TO BE USED SAFELY.

    Description of Event or Problem · 1

    THE OMNIGUIDE REGIONAL SALES DIRECTOR ASKED THE SURGEON HOW HIS PT DID AFTER A SURGICAL PROCEDURE, WHICH INCLUDED USE OF THE OMNIGUIDE LAPFLEX HANDPIECE, AND HE SAID SHE DEVELOPED AN ABSCESS AFTER SURGERY. THE CAUSE OF THE ABSCESS WAS UNK. THE PROCEDURE THAT WAS PERFORMED WAS A LAPAROSCOPIC ENDOMETRIOSIS CASE.

    Description of Event or Problem · 1

    THE OMNIGUIDE REGIONAL SALES DIRECTOR ASKED THE SURGEON HOW HIS PATIENT DID AFTER A SURGICAL PROCEDURE, WHICH INCLUDED USE OF THE OMNIGUIDE LAPFLEX HANDPIECE, BEAMPATH FIBER AND FELS-25A LASER. HE SAID THE PATIENT DEVELOPED AN ABSCESS AFTER SURGERY. THE CAUSE OF THE ABSCESS WAS UNKNOWN. THE PROCEDURE THAT WAS PERFORMED WAS A LAPAROSCOPIC ENDOMETRIOSIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277279 OMNIGUIDE LAPFLEX HANDPIECE LAPAROSCOPIC ARTICULATING HANDPIECE GEX OMNIGUIDE, INC. LA150311AX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OMNIGUIDE FELS-25A LASER