AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. DURING A SURGICAL PROCEDURE, THE DEVICE WAS EXPLANTED, AND IT WAS OBSERVED THAT THE RESERVOIR WAS EMPTY. EXAMINATION ALSO REVEALED A SMALL TEAR IN THE RIGHT CYLINDER NEAR THE CORPOROTOMY SITE; HOWEVER, IT COULD NOT BE DETERMINED WHETHER THIS TEAR WAS THE SOURCE OF THE FLUID LOSS. THE ENTIRE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100544348. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).