MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFLATABLE PENILE PROSTHESIS FAMILY; PENILE PROSTHESIS, INFLATABLE

Catalog Number ES2818

Device Problem Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, non-conforming report and capa.¿ devices met specification prior to release.No trends were noted for complaints and there were no non-conforming reports or capas that were confirmed to be associated.

Event Description

According to the available information the implant removed and replaced as it had stopped working (would not pump).

Event Description

According to the available information the implant removed and replaced as it had stopped working (would not pump).

Manufacturer Narrative

Titan touch pump, cylinders 1 and 2, reservoir, and connector / tubing were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.No functional abnormalities were noted with the pump.Abrasion was noted on both exhaust tubes of the cylinders.No functional abnormalities were noted with either cylinder 1 or cylinder 2.Abrasion was noted on the inlet tube of the reservoir.A separation was noted on the inlet tube of the reservoir near the strain relief junction.This is a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.Abrasion was noted on the detached connector/tubing.No functional abnormalities were noted with the detached connector/tubing.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress to separate the inlet tube of the reservoir.A separation of this type could then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Type of Device: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): MINNEAPOLIS; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18142098
• MDR Text Key: 328189546
• Report Number: 2125050-2023-01408
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2020
• Device Catalogue Number: ES2818
• Device Lot Number: 4770032_ES28182400
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male