BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP II

    MDR report key: 15941842 · Received December 8, 2022

    Report

    Report Number
    3006451981-2022-00134
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 8, 2022
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    FZP
    UDI-DI
    20884521057866
    PMA / PMN Number
    K143644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL DEVICES: EGIAUSTND ENDOGIA ULTRA UNIV STD STAP (LOT#P2A0707); UNKNOWN EGIA TRI STAPLE (LOT#UNKNOWN); 111987 PREMIUM PLUS CEEA 28(LOT#S0KC005X). 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 A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAP LAR), THE LINEAR STAPLER WAS NOT ABLE TO LOAD. THE CLIP APPLIER HANDLE COULD BE SQUEEZED BUT THE CLIPS WAS NOT LOADING PROPERLY. THERE WAS DIFFICULTY REMOVING THE CIRCULAR STAPLER FROM THE CAVITY. THE DOCTOR HAD TO USE A BLADE TO SEPARATE THE TISSUE. TO COMPLETE THE CASE, A NEW LINEAR STAPLER HANDLE, CIRCULAR STAPLER AND CLIP APPLIER WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210968 ENDO CLIP II CLIP, IMPLANTABLE FZP COVIDIEN MEDICAL PRODUCTS 176657 J1B2818NY 20884521057866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown