MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700; PROSTHESIS, PENIS, INFLATABLE

Model Number CX/LGX

Device Problem Malposition of Device (2616)

Patient Problems Incontinence (1928); Pain (1994)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Patient had inflatable penile prosthesis (ipp) and artificial urinary sphincter (aus) placed post prostatectomy for cancer.He developed increasing pain with the ipp and the aus was not functioning to stop incontinence.Patient taken to surgery for removal of the ipp and evaluation of the aus.The aus pump was found to be mispositioned and upside down in the uppermost scrotum with the bulb pointed towards the external ring preventing it from functioning as intended.The ipp was removed along with the mispositioned aus pump.Due to placement of the proximity of the ipp pump tubing to the aus tubing, it was only drained and left in place.Aus pump was replaced and sutured in the dependent scrotum.

• Brand Name: AMS 700
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 8900 corporate square ct; jacksonville FL 32216
• MDR Report Key: 15612108
• MDR Text Key: 301835718
• Report Number: 15612108
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/30/2022,09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CX/LGX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29930 DA
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White