AMS 700 MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT WAS NOT FUNCTIONING PROPERLY. TWO WEEKS LATER UPON INSPECTION, WHEN THE PUMP WAS PRESSED IT WAS DIMPLED. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

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. 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. MODEL NUMBER/CATALOG NUMBER: 72404161 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100627057 MODEL/CATALOG DESCRIPTION: RESERVOIR UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404292 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100565618 MODEL/CATALOG DESCRIPTION: CYLINDER UNIQUE IDENTIFIER (UDI) # (B)(4).