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

Catalog Number	519150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
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.The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot comment on the condition of the device.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
According to the available information, during an implant procedure, the tubing connector failed.As the doctor applied pressure while connecting tubing between the reservoir and cylinder assembly, the connector collapsed.The doctor was able to salvage the broken connector in one piece.He was then able to use a second connector and complete the case without further incident.
Additional Manufacturer Narrative
Detached connector / tubing was received for evaluation.The damage was noted on the connector.The surfaces appear to be rough and irregular, indicating stress was exerted.Based on examination of the returned component, it was concluded that the rough and irregular surfaces on the connector indicate that sufficient stress was exerted to damage the site during the connection of the pump and reservoir.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.
Event or Problem Description
According to the available information, during an implant procedure, the tubing connector failed.As the doctor applied pressure while connecting tubing between the reservoir and cylinder assembly, the connector collapsed.The doctor was able to salvage the broken connector in one piece.He was then able to use a second connector and complete the case without further incident.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES
• Common Device Name: 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: 21072672
• Report Number: 2125050-2025-00021
• Device Sequence Number: 19687497
• Product Code: FHW
• UDI-Device Identifier: 05701780276979
• UDI-Public: 05701780276979
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 519150
• Device Lot Number: 9945082_5191501400
• 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: 01/03/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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: 77 YR
• Patient Sex: Unknown