BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 123948 · Received October 2, 1997

    Report

    Report Number
    2125050-1997-00520
    Event Type
    Injury
    Date Received
    October 2, 1997
    Date of Event
    March 7, 1997
    Report Date
    September 8, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 4/22/1994 AND REVISED ON 3/7/1997 DUE TO "FAILURE TO PUMP." THE PHYSICIAN STATED THAT "CRACKED TUBING BETWEEN PUMP AND CYLINDER" WAS OBSERVED AND THAT LEAKAGE WAS NOTED FROM THIS SITE. PHYSICIAN FURTHER STATED THAT TUBING LENGHTS DID NOT APPEAR TO BE INADEQUATE OR EXCESSIVE, THAT THERE WERE NO KINKS OBSERVED IN TUBING, AND THAT NO INFO WAS APPARENT IN PT'S HISTORY THAT WOULD HAVE CONTRIBUTED TO THIS OCCURRENCE. ADDITIONALLY PHYSICIAN NOTED THAT OBSERVED INABILITY TO PUMP DEVICE OCCURRED "AFTER THREE YEARS OF USE." PUMP AND TWO CYLINDERS WERE RETURNED FOR EVAL. EXAMINATION AND TESTING OF RETURNED COMPONENTS REVEALED SEPARATION/LEAKAGE SITE IN NON-SERIALIZED OUTLET'S STRAIN RELIEF. EXAMINATION OF SURFACES OF SEPARATION REVEALED MARKINGS CHARACTERISTIC OF STRESS(S) INDUCED RENDING. POSTERIORLY, ADJACENT TO SEPARATION, CREASE MARK IS NOTED IN STRAIN RELIEF. BASED ON QA'S EXAMINATION AND INFO PROVIDED, QUALITY ASSURANCE CONCLUDED THE WHILE IN-VIVO NON-SERIALIZED OUTLET WAS PARTIALLY KINKED. QUALITY ASSURANCE FURTHER CONCLUDED THAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND STRAIN RELIEF AT NOTED SITE. THIS RENT WOULD ALLOW LOSS OF FLUID AND RENDER DEVICE INOPERABLE. DEVICE COMPONENTS WERE RECEIVED DETACHED. EXAMINATION OF SURFACES OF DISTAL TUBE ENDS REVEALED MARKINGS INDICATING CONTACT WITH SHARP INSTRUMENTATION ACROSS ENTIRE CROSS SECTIONAL SURFACE. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QUALITY ASSURANCE CONCLUDED THAT OBSERVED DAMAGE OCCURRED SUBSEQUENT TO DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE EXPECTED USE OF THIS DEVICE COMBINED WITH OBSERVED DAMAGED WOULD HAVE RESULTED IN SPONTANEOUS FLUID LOSS, QUALITY ASSURANCE CONCLUDED THAT DAMAGE MOST LIKELY OCCURRED DURING OR SUBSEQUENT TO EXPLANT. EVAL REPORT: DURING TESTING PUMP FAILED BOTH BACK PRESSURE AND LEAKAGE PRESSURE TESTS. EXAMINATION OF VALVE REVEALED FOREIGN MATERIAL AROUND OUTLET SPRING BALL ASSEMBLY, HINDERING SPRING'S FUNCTION. HOWEVER BECAUSE PHYSICIAN STATED THAT FLUID LOSS WAS OBSERVED DUE TO CRACK IN TUBING, WHICH WOULD LEAD TO FAILURE TO PUMP, AND BECAUSE PHYSICIAN INDICATED THAT PT USED DEVICE SUCCESSFULLY FOR THREE YEARS BEFORE THIS OCCURRENCE. QUALITY ASSURANCE CONCLUDED THAT OBSERVED ABNORMALITIES DURING TESTING WERE MOT LIKELY DUE TO PRESENCE OF FOREIGN MATERIAL AROUND SPRING AND THAT THIS FOREIGN MATERIAL MOST LIKELY ENTERED PUMP COMPONENT DURING OR SUBSEQUENT TO REMOVAL OF DEVICE.

    Description of Event or Problem · 1

    PER IN THE INFO PROVIDED TO THE CO BY THE PHYSICIAN'S OFFICE, VIA THE CO'S INTERNATIONAL REP, THE DEVICE WAS REMOVED DUE TO "FAILURE TO PUMP-CRACKED TUBING FROM (THE) PUMP TO (THE) CYLINDER." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE PRODUCED BY THE SAME MFR. 9/8/97-IN THE INFO REQUESTED FROM THE PHYSICIAN/SURGEON, HE STATED THAT THERE WAS "LEAKAGE FROM (THE) PUMP TO (THE) CYLINDER."

    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 E90115/E90065/R90109

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention