AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100478189. MODEL/CATALOG DESCRIPTION: RESERVOIR, FLAT, IZ, 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. INFLATION ISSUE, FLUID LEAK AND HOLE/PERFORATED ARE 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 AN INABILITY TO INFLATE THE DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE DEVICE HAD EXPERIENCED FLUID LOSS DUE TO TUBING THAT HAD COMPLETELY TORN IN HALF, LEADING TO THE RIGHT CYLINDER; THEREFORE, THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS.