BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHALLENGER TI-P HANDLE

    MDR report key: 8491288 · Received April 8, 2019

    Report

    Report Number
    9610612-2019-00259
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 21, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    FZP
    PMA / PMN Number
    K081031
    Adverse Event
    Yes
    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. (B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. (B)(4)). EXEMPTION NUMBER: E2014018. INVESTIGATION: DURING A VISUAL INSPECTION WE FOUND, THAT THE MAJOR PART OF THE SCREW-THREAD IS SHEARED OFF. THERE ARE NO OTHER PARTS (LIKE THREAD PIECES) RECEIVED. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THERE ARE NO FURTHER COMPLAINS WITH THIS BATCH AND ERROR PATTERN AT HAND. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE FOR THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE: WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES WE ASSUME, THAT THE SHAVING WAS GENERATED BY SCREWING IN THE SCREW WITH A WRONG ANGLE, SO THAT THE THREAD SCRAPES ON THE EDGE OF THE PLACE (SCREW HOLE). THIS IS THE BASIC CAUSE IN CASES LIKE THAT. A MATERIAL DEFECT OR A MANUFACTURING ERROR CAN BE EXCLUDED. NO CAPA NECESSARY. ASSOCIATED MEDWATCH: 9610612-2019-00258.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). 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 CLIP MAGAZINE BROKE INTRA-OPERATIVELY. DURING ROBOTIC SURGERY FOR PROSTATE MALIGNANT TUMOR, THE CLIP MAGAZINE BROKE. IT WAS NOTED THE PART OF THE CLIP MAGAZINE (DISTAL END) WAS BROKEN AND ITS BROKEN PIECE WAS MISSING (MOST LIKELY REMAINING IN THE PATIENT.) THE SURGEON STATED THAT THE CLIP MAGAZINE DETACHED FROM THE APPLIER AFTER A FEW INSTANCES/TIMES OF CLIPPING. A REVIEW OF THE INTRA-OPERATIVE VIDEO WAS DONE BUT IT COULD NOT BE VERIFIED/CONFIRMED HOW OR WHEN THE CLIP MAGAZINE BROKE. THE SURGEON SEARCHED FOR THE BROKEN PART IN THE ABDOMEN, BUT WAS UNABLE TO FIND ANY PLASTIC PARTS OF THE DEVICE. THE SURGEON ELECTED TO CLOSE THE INCISION AS IT WAS UNLIKELY THAT THE PLASTIC PART WOULD BE FOUND. NO PATIENT INFORMATION HAS BEEN PROVIDED. ASSOCIATED MEDWATCHES: 9610612-2019-00215, 9610612-2019-00216.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284438 CHALLENGER TI-P HANDLE LIGATION / VESSEL CLIPS FZP AESCULAP AG PL520R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R