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

Catalog Number	ES2818
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the implant cylinders were flat after 20cc was put into system.10cc was put in then another 10cc was added to the pump and checked for air in the pump ball.This was done a few times to make sure all the air was all out.After insertion, the doctor said one cylinder was not inflating.The cylinder was removed from the patient and tried again; it did not inflate.The doctor removed the other cylinder (that was working) and put a second implant cylinder and pump in which worked fine.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
Additional Manufacturer Narrative
Titan touch pump and cylinders 1 and 2 were received for evaluation.A partial occlusion was noted in the exhaust tubing of the pump.Fluid was not flowing consistently during the pump fill test.No functional abnormalities were noted with either cylinder 1 or cylinder 2.The senior research and development product support manager reviewed the returned pump.During this review, it was noted that shorter exhaust tubing was partially occluded.The source of the occlusion was unknown therefore a manufacturing investigation was done by quality engineering to further investigate the lot and associated production steps related to the reported complaint.It was concluded that no issues were seen during in-process testing on the pump assembly used within this complaint unit.This in process testing looks for steady flow out of both exhaust tubes.Additionally, no nc, capa, or deviation activity was found to be associated with this work order.There were no complaint trends for this lot.Given the information collected during investigation, a root cause for the issue noted in the complaint was not identified as no discrepancies were found during dhr review.
Event or Problem Description
According to the available information the implant cylinders were flat after 20cc was put into system.10cc was put in then another 10cc was added to the pump and checked for air in the pump ball.This was done a few times to make sure all the air was all out.After insertion, the doctor said one cylinder was not inflating.The cylinder was removed from the patient and tried again; it did not inflate.The doctor removed the other cylinder (that was working) and put a second implant cylinder and pump in which worked fine.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Common Device Name: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23526910
• Report Number: 2125050-2025-01776
• Device Sequence Number: 21350766
• Product Code: FHW
• UDI-Device Identifier: 05708932539128
• UDI-Public: 05708932539128
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ES2818
• Device Lot Number: 10332371_ES28182400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male