AMS 700 CX

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404310 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100723671 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. MECHANICAL ISSUE AND CYLINDER HOLE ARE 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 THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO THE HOSPITAL WITH A NON-FUNCTIONAL DEVICE. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED AND UPON INSPECTION, THERE WAS A CRACK FOUND IN THE CYLINDER CONNECTING TUBING. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED BOTH CYLINDERS AND THE PUMP. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WAS NO ADDITIONAL INFORMATION PROVIDED.