AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100035228 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4). THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. HOLE/PERFORATED IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A CYLINDER RUPTURE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.