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

Model Number UNKNKOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 08/12/2016

Event Type  malfunction  

Event Description

The penile prosthesis that had been originally implanted in 2002 had failed.The patient was taken to the main operating room for explanting of the malfunctioning penile prosthesis and replacement with a new coloplast surgical (titan) penile prosthesis.

Manufacturer Narrative

The following elements have blank data.Unique device identifier (udi): for type of device: prosthesis, penis, inflatable.Device serial #: for type of device: prosthesis, penis, inflatable.Device model #: for type of device: prosthesis, penis, inflatable.Device lot #: for type of device: prosthesis, penis, inflatable.Device catalog (ref) #: for type of device: prosthesis, penis, inflatable.

Event Description

The penile prosthesis that had been originally implanted in 2002 had failed.The patient was taken to the main or for explanting of the malfunctioning penile prosthesis and replacement with a new coloplast surgical (titan) penile prosthesis.

• Brand Name: AMS 700
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, LLC; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 5982794
• MDR Text Key: 55792664
• Report Number: 5982794
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2016,09/16/2016

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 Operator: No Information
• Device Model Number: UNKNKOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2016
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR