AMS 700 CXR

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404310 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100757810 MODEL/CATALOG DESCRIPTION: PUMP MS UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404161 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100812785 MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC 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.

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 CONFIRMED A CRACK IN THE CYLINDER CONNECTING TUBE. THE DEVICE COMPONENTS WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR REMAINED IMPLANTED AND WAS NOT REPLACED. THERE WERE NO PATIENT COMPLICATIONS.