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

Catalog Number	519170 / 91-9480SC
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, during priming, the device had a small issue with air being pumped into the pump.It was noted that this was a first-time scrub nurse doing the preparation.The issue was noted again on the table doing surrogate reservoir.Air was pulled into the pump bulb upon squeezing it.This was cleared by clamping the white tubes, pressing the button on the pump, squeezing the bulb and aspirating with the syringe.Both times the air was sucked in again.The green tip [accessory] and syringe were swapped, and the situation was solved.There was no adverse effect on patient.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and there were no related nonconformities.No trends were noted for complaints and there were no capas that were confirmed in veeva to be associated.

• 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: 19271530
• Report Number: 2125050-2024-00720
• Device Sequence Number: 6996974
• Product Code: FHW
• UDI-Device Identifier: 05708932519847
• UDI-Public: 05708932519847
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 05/08/2024

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: 519170 / 91-9480SC
• Device Lot Number: 9515722_5191701022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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 Sex: Unknown