MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR SCROT ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number ESR9182400

Device Problems Material Erosion (1214); Leak/Splash (1354)

Patient Problems Erosion (1750); No Information (3190)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

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 device appears to have a leak in the system.Doctor said when you pump it, all you get is air.Additional information stated air in pump, possible tubing erosion.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump, two cylinders, reservoir and detached inlet tube with connector were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion on the exhaust tube of cylinder 2 near the base.Testing revealed this to be a site of leakage.Abrasion was noted on all pump tubes and detached inlet tube.No functional abnormalities were noted with the pump, cylinder 1, reservoir or detached inlet tube with connector.Based on recreation of the position of the tubes according to the abrasion pattern, this demonstrates that all pump tubes were overlapping one another while in-vivo.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to cause a separation through the exhaust tube of cylinder 2 near the base.A separation of this type would 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 OTR SCROT ZERO ANG
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9125895
• MDR Text Key: 160246059
• Report Number: 2125050-2019-00820
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487665
• UDI-Public: 05708932487665
• 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
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ESR9182400
• Device Catalogue Number: ESR918
• Device Lot Number: 3739912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR