BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELOAD FOR 60MM

    MDR report key: 2870349 · Received December 12, 2012

    Report

    Report Number
    3005075853-2012-05637
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT DEVICE WAS USED WITH THIS RELOAD? ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SURGICAL VIDEO OF THE PROCEDURE WAS RECEIVED AND IT IS BELIEVED THAT THE COMPLICATION EXPERIENCED AFTER THE FIRING OF THE SUBJECT BLACK STAPLE CARTRIDGE (ECR60T) FALLS INTO A TISSUE MANAGEMENT CATEGORY, AND IN THIS PARTICULAR SITUATION THERE WAS NOT ENOUGH TIME ALLOWED BETWEEN THE CLOSING OF THE DEVICE (STARTING THE TISSUE COMPRESSION TIME) AND THE START OF THE FIRING CYCLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF BAND AND GASTRIC SLEEVE THE DEVICE CAUSED BLEEDING, TISSUE DESTRUCTION AND B SHAPED STAPLES NOT COMPLETELY FORMED AND EVEN SOME OF THEM REMAIN OPEN. SO THE SURGEON WAS SUTURING OVER THE STAPLE LINE TO OVERCOME THESE ISSUES WHICH TAKE TIMES AND MORE EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELOAD FOR 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR