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

Catalog Number ES2916

Device Problem Failure to Pump (1502)

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

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the device was replaced due to a pump failure.No other adverse patient effects were reported.

Event Description

According to the available information, the device was replaced due to a pump failure.No other adverse patient effects were reported.

Manufacturer Narrative

Titan touch pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A group of partial separations, surrounded by abrasion, were noted on both exhaust tubes of the pump (note 2).These were not sites of leakage.A failure of the back pressure, inlet valve, leakage pressure and deflate valve tests were noted with the pump as the balls in the pump failed to seat properly.It was determined that foreign material was noted in the spring/ball and seat component of the pump.Separations were noted on the exhaust tubes of both cylinders by the strain relief junction.These are sites of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with the separations indicates that sufficient stress was exerted both exhaust tubes of cylinder and cylinder 2 near the cylinder strain relief to separate the sites while in-vivo.Separations of this type could then allow the loss of fluid, making the device inoperable.However, as additional information was not received, it could not be determined if one or all sites were the cause for the reported failure.Review of the returned pump was conducted.During this review, it was concluded that the foreign material noted in the spring/ball and seat component of the pump resulted in the failure of the back pressure, inlet valve, leakage pressure and deflate valve tests.Because these components were released according to manufacturing and quality control procedures, it was concluded that the foreign material observed most likely entered the system after the device packaging was opened.Failure of these tests were not associated with the cause of the reported device malfunction.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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17995335
• MDR Text Key: 326375022
• Report Number: 2125050-2023-01295
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ES2916
• Device Lot Number: 7988092_ES29161022
• Date Device Manufactured: 05/05/2021
• 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
• Treatment: TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES; TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES; TITAN INFLATABLE PENILE PROSTHESIS FAMILY; TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male