MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 720074-01

Device Problems Crack (1135); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 02/12/2016

Event Type  Injury  

Event Description

It was reported the patient had his spectra penile prosthesis removed and replaced due to cylinder "creak".No patient complications were reported in relation to this event.

Manufacturer Narrative

The two spectra penile prosthesis cylinders were visually inspected.One cylinder was separated into two parts approximately 4.2 cm from the rear tip.The other cylinder was almost separated into two parts approximately 4.2 cm from the rear tip.Both cylinders had a fractured wire bundle.The outer tubes were separated into two parts due to fatigue.

Event Description

It was indicated that the spectra penile prosthesis was removed and replaced due to cylinder "crack".

Manufacturer Narrative

Both cylinders were dissected and the segments pulled apart.The wire apparently fractured between the 3rd and 4th segments from the rear tip end.The wires for both cylinders were measured in multiple locations not at the break.The wires measure between.036" and.037" in thickness.The reference measurement for this dimension is.036".The third segments have apparent wear from the wire at the wire hole and wear around the edge of the segment.

Event Description

The device was removed due to patient dissatisfaction.It was indicated that the physician cut the prosthesis into pieces when removing from the patient due to severe stenosis.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5525651
• MDR Text Key: 41118452
• Report Number: 2183959-2016-00093
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2018
• Device Catalogue Number: 720074-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/01/2016; 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR