BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPOSE ULC

    MDR report key: 22040730 · Received May 16, 2025

    Report

    Report Number
    9612501-2025-01310
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 8, 2025
    Report Date
    August 1, 2025
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GDT
    UDI-DI
    10884521104365
    PMA / PMN Number
    K900486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANT PRODUCTS: 8886803512, 8886803512 APPOSE ULC 35 REG SKIN STAP (LOT J4M2562LY); 8886803512, 8886803512 APPOSE ULC 35 REG SKIN STAP (LOT J4M2562LY); 8886803512, 8886803512 APPOSE ULC 35 REG SKIN STAP (LOT J4M2562LY); 8886803512, 8886803512 APPOSE ULC 35 REG SKIN STAP (LOT J4M2562LY) 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: D4(UDI), D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE INSTRUMENT WAS RECEIVED PARTIALLY APPLIED WITH STAPLES REMAINING. THE BLADE OF THE STAPLER WAS BENT WITH STAPLES ALIGNED PROPERLY IN THE CARTRIDGE. FUNCTIONAL TESTING NOTED THAT THE HANDLE COULD BE ACTUATED; HOWEVER, THE STAPLES WERE IMPROPERLY FORMED DUE TO A BENT BLADE. IT WAS REPORTED THAT THERE WAS TISSUE HANG-UP, THE SKIN STAPLER INSTRUMENT DID NOT FIRE, AND THE STAPLER HUNG UP DURING USE. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: THE INSTRUMENT NOSE IS PLACED GENTLY ON THE APPROXIMATED TISSUE WITH THE DIRECTIONAL ARROW IN THE MIDDLE OF THE INCISION. SQUEEZE THE TRIGGER COMPLETELY AND RELEASE. FAILURE TO COMPLETELY SQUEEZE THE TRIGGER MAY RESULT IN INCOMPLETE STAPLE FORMATION AND INSUFFICIENT WOUND APPROXIMATION. REPEAT THIS PROCEDURE, TAKING CARE TO SPACE THE STAPLES EVENLY, UNTIL THE INCISION IS COMPLETELY CLOSED; ANY MALFORMED STAPLES SHOULD BE REMOVED AND REPLACED WITH A NEW STAPLE. 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

    IT WAS REPORTED THAT DURING A BILATERAL ARM LIFTS AND BILATERAL THIGH LIFTS PROCEDURE, IN SKIN CLOSURE, THE STAPLE SEEMS TO DEPLOYED AND ONE SIDE OF THE STAPLER WAS IN THE EDGE OF THE SKIN AND THE OTHER SIDE WAS STACKED OR JAMMED IN THE DEVICE. THE SURGEON TRIED TO FIRE IT AGAIN TO RELEASE THE SKIN BUT THE STAPLER KEEP JAMMING INSIDE. THE SURGEON HAD TO RELEASE THE STAPLER FROM THE SKIN WITH A MOSQUITO CLIP WHILE THE SKIN WAS JAMMED IN THE TIP OF STAPLER, SO THE EDGE OF THE SKIN WAS SLIGHTLY DAMAGE. THIS ISSUE OCCURRED ON A TOTAL OF FIVE SKIN STAPLERS. IT WAS NOTED THAT THE SURGEON HAD TO CHOOSE A ¿HEALTHY¿( FRESH) SKIN EDGE TO APPLY NEW STAPLERS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164140 APPOSE ULC STAPLE, REMOVABLE (SKIN) GDT DAVIS & GECK CARIBE LTD 8886803512 J4M2562LY 10884521104365

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female SEE H11.