BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR

    MDR report key: 2861361 · Received December 7, 2012

    Report

    Report Number
    3005075853-2012-05492
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. SURGICAL VIDEO RECEIVED AND BASED ON THE EVENT DESCRIPTION AND VIDEO EVIDENCE, IT IS BELIEVED THE SPECIFIC CAUSE OF THE COMPLICATION WAS FIRING ACROSS EXISTING STAPLE LINES AT AN ANGLE THAT DID NOT ALLOW THE KNIFE TO SLIDE PAST THE STAPLES. RESULTING IN TISSUE PLOWING PULLING AND DAMAGING THE KNIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRECTOMY, THE DEVICE WAS FIRED PROPERLY FOR THE OTOMY CLOSING AT THE 1ST FIRING AFTER THE HERNIA STAPLER (COVIDIEN) WAS FIRED FOR A TEMPORARY CLOSING DURING A DELTA-SHAPED ANASTOMOSIS. AFTER THAT, ALTHOUGH THE SAME DEVICE LOADING 6R45B WAS FIRED AT THE 2ND FIRING, IT COULD NOT CUT, BUT THE STAPLES WERE DEPLOYED. WHEN ANOTHER 6TB45 WAS FIRED, IT COULD NOT CUT, BUT THE STAPLES WERE DEPLOYED AS WELL AND THE BLUE CARTRIDGE FRAGMENTS AND THE ORANGE STAPLE DRIVER FRAGMENTS WERE FOUND ON THE 2ND FIRING STAPLE LINE. THE UNCUT TARGET TISSUE WAS CUT WITH A SCISSORS AND ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. REGARDING THE 2ND FIRING WITH 6R45B, THE THICKNESS OF THE TARGET TISSUE WAS NORMAL AND THE DEVICE DID NOT CLAMP A MULTIPLE-STACKED TARGET TISSUE ACCORDING TO THE PROCEDURE VIDEO. THE DOCTOR COMMENTED THAT THE DEVICE MIGHT HAVE BEEN FIRED ON THE STAPLE LINES OF HERNIA STAPLER. REINFORCEMENT MATERIAL WAS NOT USED. THE FIRING FORCE WAS HIGHER THAN EXPECTED. THERE WAS NO UNEXPECTED SOUND AT THE FIRING. THE FIRING TRIGGER WAS GRASPED FULLY. ALL STAPLE LINES WERE FORMED ACCORDING TO THE PROCEDURE VIDEO. SOME STAPLES WERE FORMED AS INTENDED AND SOME WERE UNFORMED. REGARDING THE FIRING OF THE 2ND 6TB45, THE DEVICE WAS FIRED ON AN EXISTING STAPLE LINE OF THE 1ST 6TB45 ON THE GASTRIC BODY OF THE PATIENT SIDE. THERE WAS NO UNEXPECTED RESISTANCE WHILE CLOSING. THERE WAS AN UNEXPECTED RESISTANCE AT THE FIRING. THE FIRING TRIGGER WAS GRASPED FULLY. ALL STAPLE LINES WERE DEPLOYED. SOME STAPLES WERE FORMED AS INTENDED AND SOME WERE DEPLOYED. NO BLEEDING AND NO LEAK WERE CONFIRMED. THERE WAS A POSSIBILITY THAT SOME FRAGMENTS WERE NOT REMOVED FROM THE PATIENT. THE DOCTOR CONSIDERED THAT SOME FRAGMENTS HAD BEEN LEFT INSIDE THE PATIENT AND THEY WERE NO HARM FOR THE PATIENT. AS OF (B)(6) THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1