BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURSTRING

    MDR report key: 20465001 · Received October 16, 2024

    Report

    Report Number
    2647580-2024-04444
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    October 2, 2024
    Report Date
    January 10, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDJ
    UDI-DI
    10884521051430
    PMA / PMN Number
    K901107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 020242, 020242 DISP PURSE STRING 65 X3 (LOT#P9K1482Y). 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

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE PUSHERS ARE FULLY DEPLOYED. THE CARTRIDGES WERE PROPERLY SEATED AFTER FIRING. NO VISUAL ABNORMALITIES WERE OBSERVED. IT WAS REPORTED THAT THE INSTRUMENT DID NOT FIRE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 RESECTION OF MALIGNANT TUMOR OF THE SIGMOID COLON, THE HANDLE WAS SQUEEZED, THE JAWS WERE CLOSED, THE HANDLE LOCK WAS ENGAGED, AND THE FIRING OPERATION WAS PERFORMED. HOWEVER AFTER RESECTING THE TISSUE ALONG THE JAWS WITH A SCALPEL, AND OPENING THE JAWS, THE STAPLE DID NOT ENGAGE ON THE TISSUE, AND IT WAS NOT POSSIBLE TO PERFORM THE PURSE-STRING SUTURE WITH THE PRODUCT'S SUTURE. A SECOND DEVICE WAS USED AND ANOTHER TISSUE RESECTION WAS PERFORMED HOWEVER THE SAME ISSUE OCCURRED. THE SURGEON HAND SEW THE COLON PURSE STRING TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374930 PURSTRING CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY GDJ US SURGICAL PUERTO RICO 020242 P9K1482Y 10884521051430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown