AMS 700 LGX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100814108. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY AND EXHIBITED INFLATION ISSUES. AN ULTRASOUND AND COMPUTED TOMOGRAPHY WERE PERFORMED, AND A FLUID LOSS WAS IDENTIFIED. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND TESTED, SHOWING NO SOURCE OF LEAK. THE CYLINDERS WERE EXPLANTED AND TESTED SHOWING SMALL LEAK THROUGH SMALL HOLE IN RIGHT CYLINDER, SUSPECTED TO BE RELATED TO A PUNCTURE. ADDITIONALLY, AIRE WAS OBSERVED IN THE DEVICE. BOTH RESERVOIR AND CYLINDERS/PUMP REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.