BEUDAMED
    FDA Adverse Event Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3103246 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02211
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REVIEW OF THE INFORMATION PROVIDED THROUGH PRODUCT ANALYSIS, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND HAS BEEN UPDATED TO NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WAS THE DEVICE DIFFICULT TO OPEN? - NO. THE SALE REP REPORTED THAT THE DOCTOR'S COMMENT HAD BEEN REPORTED WRONGLY. THE COMMENTS BELONGED TO ANOTHER COMPLAINT. SORRY FOR CONFUSION. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? - AT THE 2ND FIRING. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? -- BLOOD VESSEL. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? -- YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? - THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WERE ANY UNEXPECTED NOISES HEARD? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? -- NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? -- NO. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? -- THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, TWO CLIPS WERE DEPLOYED AT A TIME WHEN THE DEVICE WAS USED ON THE BLOOD VESSEL. THERE WAS NOT A FEELING OF STRANGENESS AT FIRING. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR COMMENTED THAT THE DEVICE MIGHT HAVE BEEN FIRED ACROSS SOMETHING HARD SUCH AS A CLIP AND THE JAWS MIGHT HAVE HAD A DIFFICULTY IN BEING OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202612 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1