AMS 700 MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720182-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000264241. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT 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. MECHANICAL ISSUE IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS 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 NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.