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

Model Number ES29162400

Device Problem Failure to Pump (1502)

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

Event Type  Injury  

Event Description

According to the available information, the device was explanted and replaced because it stopped pumping.

Manufacturer Narrative

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 information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.The lot # was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

Titan touch pump, cylinders 1 and 2, and detached inlet connector / tubing were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A separation, surrounded by abrasion, was noted on the shorter exhaust tube of the pump.This is a site of leakage.A failure of the pump fill, back pressure, and inlet 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.No functional abnormalities were noted with either cylinder 1 or cylinder 2.A group of striations, indicating contact with unshod instrumentation, was noted on the detached inlet connector tube.This is not a site of leakage.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 shorter exhaust tubing.A separation of this type could then allow the loss of fluid, making the device inoperable.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 pump fill, back pressure, and inlet 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.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH
• Type of Device: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 17079862
• MDR Text Key: 316700258
• Report Number: 2125050-2023-00729
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539173
• UDI-Public: 05708932539173
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2015
• Device Model Number: ES29162400
• Device Catalogue Number: ES2916
• Device Lot Number: 3851341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male