AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404156. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100754237. MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC IZ. 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. DEFLATION ISSUE, MECHANICAL ISSUE, MIGRATION AND PERFORATION 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 A DEVICE THAT WAS NO LONGER DEFLATING AND REMAINED IN AN INFLATED STATE FOR OVER ONE WEEK. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR TUBING WAS LINKED AND BOTH CYLINDERS HAD HERNIATED. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.