BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 17633252 · Received August 28, 2023

    Report

    Report Number
    2647580-2023-03661
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 28, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003550
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT/S: SIGTRSB60AXT, SIGTRSB60AXT 60MM XTR THK REINFORCED REL (LOT#N3B0356Y) EGIAUXL EGIAUXL ENDOGIA ULTRA UNIV XL STAPLER (LOT#P2M0016) UNKNOWN ENDO GI UNKNOWN ENDO GIA INSTRUMENT (LOT#UNKNOWN) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. NO INFORMATION RE GARDING THE SPECIFIC CUSTOMER ISSUE THAT OCCURRED WITH THE DEVICE WAS AVAILABLE. VISUAL INSPECTION NOTED THE INSTRUMENT FIRING KNOBS WERE RETRACTED. THE ARTICULATION LEVER WAS IN NEUTRAL POSITION. FUNCTIONALLY, THE INSTRUMENT LOADED, CLAMPED, YET WOULD NOT CYCLE DUE TO SHEARED FIRING RACK TEETH DAMAGE. THIS ISSUE MAY OCCUR IN ANY OF THE FOLLOWING CIRCUMSTANCES: 1. FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 2. FIRING WITH AN OBSTACLE INCORPORATED IN THE JAWS. 3. ATTEMPTING TO FIRE A RELOAD THAT IS IN INTERLOCK. IN EACH CIRCUMSTANCE, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY, AND TISSUE MAY NOT BE FULLY TRANSECTED. 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: PREOPERATIVE RADIOTHERAPY MAY RESULT IN CHANGES TO TISSUE. THESE CHANGES MAY, FOR EXAMPLE, CAUSE THE TISSUE THICKNESS TO EXCEED THE INDICATED RANGE THICKNESS FOR THE STAPLE SIZE. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ANY PRE-SURGICAL TREATMENT THE PATIENT MAY HAVE UNDERGONE AND IN CORRESPONDING SELECTION OF STAPLE SIZE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY, ON THE FIRST STAPLING OF THE LOAD, THE DEVICE STOPPED FIRING HALFWAY ACROSS AND THERE WAS A SNAPPING NOISE FROM THE HANDLE THAT IS FROM THE SAFETY MECHANISM. ANOTHER HANDLE AND A NEW NON REINFORCED RELOAD THROUGH THE JAMMED BUTTRESS WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT SHEARED TEETH WERE VISIBLE ON THE FIRING RACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434345 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUXL P2K0422 10884523003550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10