BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESARABLUE TV EZ 3.0 CAL-DSB01TV30

    MDR report key: 23406039 · Received October 28, 2025

    Report

    Report Number
    3003990090-2025-01687
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    February 4, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    PWJ
    UDI-DI
    00890594000124
    PMA / PMN Number
    K162201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, AND THE RESULTS WILL BE REPORTED. THE MANUFACTURING NUMBER IS C25-2875.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D5, H3, H6, H11. INVESTIGATION RESULTS: THE INVESTIGATION FOUND THAT THE DEVICE ITSELF MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS, WITH THE DEVICE HISTORY RECORD SHOWING NO NONCONFORMITIES. A CROSS-FUNCTIONAL REVIEW SUGGESTED THAT RESISTANCE DURING SLING ADVANCEMENT, POSSIBLY COMBINED WITH THE TROCAR NOT BEING FULLY SEATED OR IMPROPER DEVICE LOADING, LED TO THE PUNCTURE. THE REPORT CONCLUDES THAT THE PRIMARY CONTRIBUTING FACTOR WAS USER ERROR RELATED TO SURGICAL TECHNIQUE AND EXCESSIVE FORCE DURING DEVICE ADVANCEMENT. GIVEN THESE FINDINGS, NO IMMEDIATE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) ARE PROPOSED, AND THE COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH ROUTINE POST-MARKET SURVEILLANCE. THE INVESTIGATION WILL BE RE-EVALUATED IF NEW INFORMATION ARISES. THE MANUFACTURING NUMBER IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON ADVANCED THE SLING THROUGH THE PATIENT AS USUAL, AND THE TROCAR CAME THROUGH JUST AT THE END OF THE BLUE DILATOR TUBE. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL; ANOTHER SLING WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028316 DESARABLUE TV EZ 3.0 CAL-DSB01TV30 DESERA BLUE PWJ CALDERA MEDICAL INC. CAL-DS01BTV30 00890594000124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female