BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIVA 0913-12

    MDR report key: 22329253 · Received June 25, 2025

    Report

    Report Number
    1222780-2025-00345
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    May 29, 2025
    Report Date
    October 7, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420045505322
    PMA / PMN Number
    K180233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED: IT WAS REPORTED THAT ON (B)(6) 2025, DURING AN EVIVA PROCEDURE, THE USER REPORTED THE EVIVA PETITE BLUNT BIOPSY NEEDLE WOULD NOT FIRE. THE USER WAS GUIDED BY HOLOGIC TECHNICAL SUPPORT ON HOW TO INSTALL THE EVIVA PETITE BLUNT BIOPSY NEEDLE ONTO THE SYSTEM. ADDITIONALLY, IT WAS REPORTED THAT THE USER WAS NOT UTILIZING THE STYLET HOLDER TO HOLD THE STYLET IN PLACE DURING THE INITIAL BIOPSY ATTEMPT. IT WAS REPORTED THAT THE USER WAS ABLE TO UTILIZE THE STYLET HOLDER AND COMPLETE A SUCCESSFUL BIOPSY; HOWEVER, THE PATIENT REQUIRED A SECOND INCISION TO DO SO. NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE WAS NOT AVAILABLE FOR RETURN; VISUAL AND FUNCTIONAL ANALYSIS/TESTING COULD NOT BE CONDUCTED FOR THE DESCRIBED EVENT. THE DEVICE WAS NOT RETURNED FOR THIS COMPLAINT, AND ONLY LIMITED PATIENT-RELATED INFORMATION WAS PROVIDED. THEREFORE, A FULL INVESTIGATION COULD NOT BE CONDUCTED. BASED ON THE AVAILABLE INFORMATION, THE CUSTOMER REPORTED THAT THE STYLET HOLDER WAS NOT USED DURING THE PROCEDURE. THIS INFORMATION WAS CONSIDERED RELEVANT TO THE FAILURE MODE. INVESTIGATION FOR THIS ISSUE WAS CONDUCTED THROUGH CUSTOMER PROVIDED INFORMATION, HISTORICAL DATA REVIEW, SIMILAR COMPLAINTS ANALYSIS, AND PRODUCT DESIGN EVALUATION. WITHOUT THE RETURNED DEVICE, IT IS NOT POSSIBLE TO CONFIRM A DEFINITIVE ROOT CAUSE OF THE ISSUE. ROOT CAUSE ANALYSIS DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE; ONLY A CONTRIBUTING FACTOR (NO USE OF STYLET HOLDER DURING THE PROCEDURE) WAS FOUND TO BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR THIS COMPLAINT, AND ONLY LIMITED CUSTOMER INFORMATION WAS PROVIDED, WHICH RESTRICTED THE SCOPE OF THE INVESTIGATION. CONCLUSION: THE REPORTED ISSUE HAS BEEN CONFIRMED BASED ON CUSTOMER INFORMATION. THE RISK INDEX FOR THIS SITUATION IS WITHIN THE RANGE ALREADY CALCULATED IN THE RISK TRENDING AND IT IS PROBABLE THAT THIS IS AN ISOLATED ISSUE AND NOT RECURRING PROBLEM WITHIN THE PRODUCT FAMILY, SYSTEM OR FAILURE MODE REPORTED IN THE COMPLAINT. THE EVENT DOES NOT TRIGGER ESCALATION TO NCE, SCAR, OR CAPA. FUTURE EVENTS WILL BE MONITORED AND TRENDED. DEVICE HISTORY RECORD (DHR) REVIEW: THE DHR REVIEW WAS NOT CONDUCTED SINCE THE LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT ON (B)(6) 2025, DURING AN EVIVA PROCEDURE, THE USER REPORTED THE EVIVA PETITE BLUNT BIOPSY NEEDLE WOULD NOT FIRE. THE USER WAS GUIDED BY HOLOGIC TECHNICAL SUPPORT ON HOW TO INSTALL THE EVIVA PETITE BLUNT BIOPSY NEEDLE ONTO THE SYSTEM. ADDITIONALLY, IT IS REPORTED THAT THE USER WAS NOT UTILIZING THE STYLET HOLDER TO HOLD THE STYLET IN PLACE DURING THE INITIAL BIOPSY ATTEMPT. IT IS REPORTED THAT THE USER WAS ABLE TO UTILIZE THE STYLET HOLDER AND COMPLETE A SUCCESSFUL BIOPSY; HOWEVER, THE PATIENT REQUIRED A SECOND INCISION TO DO SO. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069766 EVIVA 0913-12 INSTRUMENT, BIOPSY KNW HOLOGIC, INC EVIVA_0913-12 15420045505322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown