BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAR TIP EXTENDER

    MDR report key: 23922901 · Received December 30, 2025

    Report

    Report Number
    2124215-2025-93536
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 4, 2025
    Report Date
    May 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    N/A
    UDI-DI
    00878953004112
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET/510(K) EXCEEDED THE CHARACTER LIMIT; THE FULL NUMBERS ARE: K090663, N970012. D2B: PRO CODE (PRODUCT CODE) EXCEEDED THE CHARACTER LIMIT; THE FULL NUMBERS ARE: FAE, JCW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PREPARATION OF AN IMPLANTATION OF THIS INFLATABLE PENILE PROSTHESIS (IPP) STACKABLE RTES WERE OPENED BY THE CIRCULATOR AND PASSED TO THE SCRUB TECHNICIAN, THE PACKAGING WAS NOT DAMAGED PRIOR TO OPENING. THE SCRUB TECH PREPPED THE IPP CYLINDERS AND DUMPED THE RTES OUT ONTO THE BACK TABLE TO ATTACH THEM TO THE CYLINDERS AND NOTED A HAIR ON ONE OF THE RTES. THE HAIR WAS INSIDE THE PACKAGING. AS A RESULT, THE PROCEDURE WAS COMPLETE WITH ANOTHER RTE. THE TECH RETAINED THE CONTAMINATED RTES TO SHOW HER MANAGER, BUT NO PICTURES WERE AVAILABLE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340738 REAR TIP EXTENDER PROSTHESIS, PENILE N/A BOSTON SCIENTIFIC CORPORATION 72404330 1100805875 00878953004112

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male