AMS 700 MS PUMP

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN FOUND CRACK IN THE PUMP CONNECTING TUBE. THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404161, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 0172108013, MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404013, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 0169860008, MODEL/CATALOG DESCRIPTION: CXR 16CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). 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. MECHANICAL ISSUE AND HOLE/PERFORATED ARE ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. 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.