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

Catalog Number	519150
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
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, coloplast 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, the crimping tool damaged the centerpiece connector.Another connector was used to successfully complete the implant procedure.
Additional Manufacturer Narrative
The device was not returned for evaluation.A photograph of the connector was provided.In the picture it can be see that the connector is damaged; however, without the benefit of analyzing the device, quality cannot confirm root cause of the damage based on the photograph alone.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Based on the submitted information, it alleges the damage was done by the user.It suggests the connector tool may have been utilized incorrectly causing damage to the connector.The ifu indicates the titan inflatable penile prosthesis should only be implanted by physicians experienced in the surgical procedures and techniques involving implantation of a penile prosthesis.The physician should maintain adequate education to conduct this procedure.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, nonconformance's and capas revealed no trends for this lot.
Event or Problem Description
According to the available information, the crimping tool damaged the centerpiece connector.Another connector was used to successfully complete the implant procedure.

• 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: 20819344
• Report Number: 2125050-2024-01985
• Device Sequence Number: 8716929
• Product Code: FHW
• UDI-Device Identifier: 05701780276979
• UDI-Public: 05701780276979
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/13/2025

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: 9686462_5191501400
• Was Device Available for Evaluation?: No
• 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: 12/02/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Unknown