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

Model Number ES29202400

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the tubing from one of the cylinders was frayed coming from the cylinder.The device was explanted and replaced with another inflatable device.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan touch pump, two cylinders, and a reservoir were received for evaluation.Testing revealed a separation on the cylinder 2 exhaust tubing at the tubing/strain relief junction.This was a site of leakage.Microscopic evaluation revealed surfaces of the separation site to be rough and irregular, indicating sufficient stress was exerted to separate the site.Microscopic evaluation revealed surface abrasion on cylinder 1 and cylinder 2 strain relief and both exhaust tubing, indicating repetitive contact of surfaces.No functional abnormalities were noted with the pump, cylinder 1 or the reservoir.Based on examination of the returned product, it was concluded that while in-vivo all of the pump tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to cause a separation in the cylinder 2 exhaust tubing at the tubing/strain relief junction.A separation of this type could then allow the loss of fluid, making the device inoperable.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, non-conformances and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9801885
• MDR Text Key: 183339771
• Report Number: 2125050-2020-00207
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539197
• UDI-Public: 05708932539197
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES29202400
• Device Catalogue Number: ES2920
• Device Lot Number: 4084913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR