BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 REGULAR

    MDR report key: 2183063 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03073
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED PRECOCK MECHANISM, DAMAGED ANVIL FORMER DEVICES (A) AND (B) WERE RECEIVED WITH BRITTLE CARTRIDGES AND WITH THE PRECOCK MECHANISMS DAMAGED. AFTER FURTHER INSPECTION OF THE CARTRIDGES, THE NOSES WERE NOTED TO BE OPENED; HOWEVER THE CARTRIDGE WELD WAS SUFFICIENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICES. THE DEVICES WERE DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE RETURN SPRING POSTS WERE DAMAGED AND THE ANVILS WERE NOTED TO BE DEFORMED. THIS DEFORMATION IN THE ANVIL WILL PREVENT THE STAPLE TO BE HELD IN THE FIRING CHAMBER FOR ITS COMPLETE FORMATION, RESULTING IN AN EJECTED STAPLE. THE APPROPRIATE ENGINEERING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CARTRIDGE BECAME BRITTLE, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE WAS NOT RETURNED ADDITIONAL INFORMATION: DID THE DEVICE FALL APART INTO SEVERAL PIECES?---NO. DID A STAPLE FALL OUT FROM THE DEVICE?---THE STAPLE WAS UNFORMED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP EJECTED WHEN THE TRIGGER WAS GRASPED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** SKIN STAPLER 35 REGULAR SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1