AMS 700 LGX

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404310. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100721059. MODEL/CATALOG DESCRIPTION: PUMP MS. 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. DEVICE OPERATING DIFFERENTLY THAN EXPECTED IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS NOT RELATED TO OFF LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. BASED ON THE INFORMATION AVAILABLE, THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED; THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER STRENGTH WAS WEAK. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE SURGEON ADDED ADDITIONAL SALINE SOLUTION TO THE IPP, ALL COMPONENTS WERE RETAINED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED.