BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 82807 · Received April 11, 1997

    Report

    Report Number
    2125050-1997-00192
    Event Type
    Injury
    Date Received
    April 11, 1997
    Date of Event
    February 28, 1997
    Report Date
    April 11, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 7/3/95. THE DEVICE WAS REMOVED ON 2/28/97, REPORTEDLY DUE TO "FAILURE OF INFLATION." ADD'L INFO INDICATED THAT THE DEVICE WAS REMOVED DUE TO A "PUMP CONNECTOR BROKEN." A RETURNED QUESTIONNAIRE INDICATED THAT THERE WAS A "FAILURE OF INFLATION TWO MONTHS AGO, SUDDENTLY." THERE WERE NO ABNORMALITIES WITH THE POSITIONING OR LENGTH OF THE DEVICE'S TUBING, "EXCEPT THE TUBING DISPLACED." THERE WAS NO APPARENT INFO IN THE PT'S HISTORY THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE DID NOT CONTACT ANY UNSHOD OR SHARP INSTRUMENTATION DURING REMOVAL. THE PUMP, TWO DETACHED CYLINDERS, AND A DETACHED PARTIAL CONNECTOR WERE RECEIVED BY THE MFR. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP OR CYLINDERS. THE CONNECTOR WAS NOT RECEIVED IN A CONDITION THAT WOULD ALLOW FUNCTIONAL TESTING. DURING MICROSCOPIC EXAMINATION ROUGH, IRREGULAR CROSS SECTIONAL TUBING SURFACES WERE DETECTED BETWEEN THE NON-SERIALIZED PUMP OUTLET AND CYLINDER #2. SURFACES OF THIS NATURE INDICATED A TEAR. IN ADDITION, A TUBING CREASE OF CYLINDER #2'S TUBING WAS NOTED NEAR THIS TEAR SITE, INDICATING THAT THE DEVICE WAS PARTIALLY KINKED WHILE IN-VIVO. BASED ON THE RECEIVED INFO AND QUALITY ASSURANCE'S EVALUATION, QA CONCLUDES THAT A TEAR BETWEEN THE PUMP AND A CYLINDER WAS THE REASON FOR THE REPORTED FAILURE TO INFLATE, AND THEREFORE THE REASON FOR REMOVING THE DEVICE. THE DEVICE'S IN-VIVO POSITIONING CONTRIBUTED STRESS(ES) THAT CONTRIBUTED TO THE TEAR. SINCE THE ENTIRE CONNECTOR WAS NOT RECEIVED AND SINCE IT IS NOT ABLE TO BE TESTED, QA IS PRECLUDED FROM DETERMINING IF THE CONNECTOR WAS ASSOCIATED WITH THE REASON FOR REMOVING THE DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED AS THE "PUMP CONNECTION WAS BROKEN." AS REPORTED TO CO, THE PUMP/CYLINDER SET AND SOME ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED; LEAVING THE RESERVOIR, CATALOT #9100K, SERIAL #183148 INPLACE FROM THE INITIAL IMPLANT SURGERY. 3/24/97 -UPON RECEIPT OF ADD'L INFO PROVIDED BY THE PHYSICIAN/SURGEON, HE STATED, "THE SURGICAL REVISION ADDRESSED FAILURE OF INFLATION SUDDENLY TWO MONTHS AGO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90123/R90159

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention