BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC TENOTOMY SCISSDELCVD1/SERR130MM

    MDR report key: 15214566 · Received August 11, 2022

    Report

    Report Number
    2916714-2022-00087
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A TC TENOTOMY SCISSDELCVD1/SERR130MM (PART # DO250R) WAS USED DURING A TOTAL SHOULDER REPLACEMENT SURGERY PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SCISSOR BROKE WHILE CUTTING SOFT TISSUE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. AN X-RAY WAS TAKEN INTRAOPERATIVELY; THERE WAS A DELAY OF 10-15 MINUTES. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942698 TC TENOTOMY SCISSDELCVD1/SERR130MM DENTAL EGN AESCULAP AG DO250R 04038653148301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention