AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DIFFICULT TO INFLATE AND HAD SPONTANEOUSLY INFLATED. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. PRIOR TO THE SURGERY, THE PHYSICIAN ATTEMPTED TO INFLATE AND DEFLATE THE DEVICE WITH NO ISSUES FOUND. UPON EXPLANT, THE PHYSICIAN IDENTIFIED SEVERAL BANDS OF SCAR TISSUE AROUND THE RESERVOIR WHICH THE PHYSICIAN SUSPECTED WAS THE CAUSE OF THE SPONTANEOUS INFLATION. UPON COMPLETION OF SURGERY THE PHYSICIAN INFLATED AND DEFLATED THE DEVICE SEVERAL TIMES AND DEVICE FUNCTIONALITY APPEARED NORMAL STILL. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0139350006. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).