BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBATACK

    MDR report key: 19177271 · Received April 24, 2024

    Report

    Report Number
    1219930-2024-01826
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 3, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523006506
    PMA / PMN Number
    K071920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION HAS BEEN RECEIVED, AND REASSESSMENT OF THE COMPLAINT FOUND THAT IT IS NO LONGER A REPORTABLE ISSUE. THE EVENT IS NO LONGER ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: ABSTACK15 - ABSTACK15 ABS FIXATION DEVICE 15 TACKS, LOT# N3D0157Y. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR, WHEN TACKING FOR MESH FIXATION, THE FIRST FIRING WAS ATTEMPTED IN THE COOPER LIGAMENT WITH THE FIRST TACKER, BUT THE SQUEEZING WAS STIFF AND COULD NOT BE FIRED. HOWEVER, THE TACKER TIP WAS FOUND TO BE PUSHED AGAINST THE COOPER LIGAMENT. THE DEVICE COULD NOT BE FIRED, AND IT WAS REMOVED FROM THE TROCAR AND SQUEEZED ON THE DESK ONCE, BUT IT STILL COULD NOT BE FIRED. AFTERWARDS, A SECOND TACKER FROM THE SAME LOT WAS OPENED; IT WAS ABLE TO PERFORM THE 2-3 FIRING WITHOUT ANY PROBLEMS, BUT AFTER THAT, IT STOPPED TACKING. THE TACKER WAS UNABLE TO FIRE, AND SQUEEZING COULD NOT BE DONE. A COMPETITOR'S PRODUCT WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR, WHEN TACKING FOR MESH FIXATION, THE FIRST FIRING WAS ATTEMPTED IN THE COOPER LIGAMENT WITH THE FIRST TACKER, BUT THE SQUEEZING WAS STIFF AND COULD NOT BE FIRED. HOWEVER, THE TACKER TIPWAS FOUND TO BE PUSHED AGAINST THE COOPER LIGAMENT. THE DEVICE COULD NOT BE FIRED, AND IT WAS REMOVED FROM THE TROCAR AND SQUEEZED ON THE DESK ONCE, BUT IT STILL COULD NOT BE FIRED. AFTERWARDS, A SECOND TACKER FROM THE SAME LOT WAS OPENED; IT WAS ABLE TO PERFORM THE 2-3 FIRING WITHOUT ANY PROBLEMS, BUT AFTER THAT, IT STOPPED TACKING. THE TACKER SEEMED JAMMED, AND SQUEEZING COULD NOT BE DONE. A COMPETITOR'S PRODUCT WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604522 ABSORBATACK STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN ABSTACK15 N3D0157Y 10884523006506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.