BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC TENOTOMY SCISSDELCVD1/SERR130MM

    MDR report key: 15214498 · Received August 11, 2022

    Report

    Report Number
    9610612-2022-00208
    Event Type
    Injury
    Date Received
    August 11, 2022
    Date of Event
    July 13, 2022
    Report Date
    October 27, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    EGN
    UDI-DI
    04038653148301
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IF THE DEVICE IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL AGAIN BE COMPLETED AT THAT TIME. BASED UPON THE INVESTIGATION RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH DO250R TC TENOTOMY SCISSDELCVD1/SERR130MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SCISSOR BROKE WHILE CUTTING SOFT TISSUE. THIS OCCURRED DURING A TOTAL SHOULDER REPLACEMENT SURGERY. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. AN X-RAY WAS TAKEN INTRAOPERATIVELY; THERE WAS A DELAY OF 10-15 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249717 TC TENOTOMY SCISSDELCVD1/SERR130MM DENTAL EGN AESCULAP AG DO250R 04038653148301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention