AMS 700 LGX? TENACIO? PUMP

Additional Manufacturer Narrative

D4 UNIQUE IDENTIFIER (UDI) FOR RESERVOIR: (B)(4). THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED ISSUES WITH LENGTH TOO SHORT MAY HAVE BEEN DUE TO A POTENTIAL MEASUREMENT ERROR. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PROPERLY SIZED, TIPS SITTING TOO LOW IN CORPORA. THE IPP WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.