BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR.

    MDR report key: 8523157 · Received April 17, 2019

    Report

    Report Number
    9610612-2019-00246
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 20, 2019
    Report Date
    June 17, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    FZP
    PMA / PMN Number
    K081031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. NO PRODUCT AT HAND. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE BECAUSE THE BATCH NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE: NO PRODUCT AVAILABLE AND THEREFORE IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE. WE ASSUME THAT THE CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THE ROOT CAUSE COULD BE USAGE RELATED. RATIONALE: ACCORDING TO THE QUALITY STANDARD AND DHR FILES A MATERIAL DEFECT, PRODUCTION AND DESIGN ERROR CAN BE EXCLUDED. UNFORTUNATELY DUE TO A LOCK OF DATA AND WITHOUT THE PRODUCT WE CANNOT DETERMINE THE EXACT CAUSE. THERE IS THE POSSIBILITY THAT THE CARTRIDGE HAS NOT BEEN MOUNTED CORRECTLY. AN ADDITIONAL REASON COULD BE A CLIP JAM. THESE COULD HAVE BEEN CAUSED DUE TO A USAGE ERROR. POSSIBLY THE CLIP JAM COULD BE CAUSED DUE TO AN IMPROPER HANDLING BY A TOO FAST APPLICATION. THE TOO FAST APPLICATION COULD LEAD TO A DEFORMED SLIDER SHEET OR SOMETHING SIMILAR AND THIS COULD CAUSE THE JAMMED CLIPS. POSSIBLY A DAMAGED CLIP APPLICATOR DUE TO A DEFORMED PUSH ROD OR SOMETHING SIMILAR COULD BE ANOTHER CAUSE FOR A CLIP JAM. IF FURTHER INVESTIGATIONS ARE REQUIRED, THE COMPLAINT PRODUCT AND CLIP APPLICATOR SHOULD BE PROVIDED FOR EXAMINATION. NO CAPA NECESSARY.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CARTRIDGE LOOSENED INTRAOPERATIVELY. DURING A SURGICAL PROCEDURE THE CARTRIDGE SUDDENLY BECAME LOOSE FROM THE CHALLENGER APPLIER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED. CONCOMITANT MEDICAL PRODUCTS: CLIP APPLIER, CHALLENGER TI-P, SIZE SM, 5 MM, 205 MM. CLIP APPLIER, CHALLENGER TI-P, SIZE SM, 5 MM, 310 MM. HANDLE, CHALLENGER TI-P, SIZE ML, FOR PL606R / PL608R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317534 CHALLENGER TI-P SM-LIGAT.CLIPS 12 CARTR. LIGATION / VESSEL CLIPS FZP AESCULAP AG PL574T

    Patients

    Seq Age Sex Outcome Treatment
    1 A19PL520R| A19PL603R| A19PL604R| A19PL520R| A19PL603R| A19PL604R