AMS 700 LGX

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE LEFT CYLINDER CONNECTION TUBE WAS FOUND. THE PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

D4 UNIQUE IDENTIFIER (UDI) FOR RESERVOIR: (B)(4). D4 UNIQUE IDENTIFIER (UDI) FOR PUMP: (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY ANALYZED. THE FIRST CYLINDER WAS MICROSCOPICALLY INSPECTED AND LEAK TESTING. IT WAS FOUND A HOLE AT CORNER OF A FOLD IN THE PROXIMAL END OF THE CYLINDER. THE CYLINDER PASSED THE LEAKAGE TESTING. REGARDING THE REMAINING CYLINDER, IT WAS OBSERVED TO HAD WEAR AT FOLD IN THE PROXIMAL END AND MIDDLE OF THE CYLINDER. HOWEVER, THE CYLINDER PASSED THE LEAKAGE TEST. THE MOMENTARY SQUEEZE (MS) PUMP WAS MICROSCOPICALLY INSPECTED, AND IT WAS OBSERVED TO HAVE A HOLE FROM FATIGUE AT THE STRAIN RELIEF JUNCTION. THE MS PUMP DID NOT PASS THE LEAKAGE TEST DUE TO THE LEAK FROM FATIGUE. FINALY, THE MS PUMP DID NOT PASS THE DEFLATION TEST. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE HOLE AND LEAK IDENTIFIED IN THE PUMP COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATION OF MECHANICAL PROBLEM.

Additional Manufacturer Narrative

D4 UNIQUE IDENTIFIER (UDI) FOR RESERVOIR: (B)(4). D4 UNIQUE IDENTIFIER (UDI) FOR PUMP: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE LEFT CYLINDER CONNECTION TUBE WAS FOUND. THE PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.