AMS 700 CX MS PUMP

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A SENSATION OF INTERNAL MOISTURE WITHIN THE PENIS AND SCROTUM AND WAS UNABLE TO INFLATE THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH DAMAGE AND DELAMINATION OF THE LEFT CYLINDER WERE IDENTIFIED IN ITS DISTAL HALF. THE CYLINDERS AND PUMP WERE REMOVED, AND FOLLOWING DISCONNECTION OF THE RESERVOIR, ASPIRATION CONFIRMED THAT NO FLUID WAS PRESENT WITHIN THE SYSTEM. SUBSEQUENTLY, NEW CYLINDERS AND A NEW PUMP WERE IMPLANTED AND CONNECTED TO THE ORIGINAL RESERVOIR, WHICH WAS LEFT IN SITU. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.