AMS 700 LGX

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 THAT A CRACK WAS FOUND IN THE LEFT CYLINDER CONNECTING TUBE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4).

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). UPON RECEIPT AT THE QUALITY ASSURANCE LABORATORY, THE RETURNED COMPONENTS UNDERWENT A COMPREHENSIVE EVALUATION. MICROSCOPIC OBSERVATION IDENTIFIED CONTAMINATION (BODILY FLUID) WITHIN THE MS PUMP. THE MS PUMP KINK RESISTANT TUBING (KRT) WERE WORN TO THE FILAMENT; HOWEVER, THE MS PUMP PASSED THE LEAK TEST. MICROSCOPIC INSPECTION REVEALED THE FIRST CYLINDER EXHIBITED WEAR AT THE FOLD IN THE PROXIMAL END AND MIDDLE SECTION; ALSO, FIRST CYLINDER PASSED THE LEAKAGE TEST. SECOND CYLINDER PASSED MICROSCOPIC INSPECTION AND LEAKAGE TEST. NO DAMAGE OR ABNORMALITIES WERE FOUND. BASED ON THE AVAILABLE INFORMATION AND ANALYSIS RESULTS, THE ALLEGATION OF A DEVICE MECHANICAL ISSUE AND TUBING HOLE/PERFORATION COULD NOT BE CONFIRMED, AND 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 THAT A CRACK WAS FOUND IN THE LEFT CYLINDER CONNECTING TUBE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.