AMS 700 CX MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISSATISFACTION WITH DEVICE PUMP. UPON INSPECTION, A MINIMAL FLUID IN THE RESERVOIR WAS NOTICED. THE PHYSICIAN SUSPECTED A HOLE IN THE RESERVOIR OR CYLINDERS, POSSIBLY DUE TO SUTURE PLACEMENT OR UNRELATED SURGICAL PROCEDURE. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THE RESERVOIR WAS DRAINED, RETAINED IN PATIENT AND A NEW ONE WAS PLACED. 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. (INSERT DHR STATEMENT, REFER TO VERBIAGE DATABASE & IFU LABELING SECTION RELEVANT TO AS REPORTED). 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: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100036694 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML UNIQUE IDENTIFIER (UDI) #: (B)(4).