MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29162400

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Erosion (1750)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.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 penile prosthesis was explanted due to malfunction.Wound erosion and exposure of implant were reported.The device was damaged (tubing at pump) to facilitate explant.The implant was replaced with another device.

Manufacturer Narrative

This follow-up was created to document the conclusion of the investigation and updated device code of 3191.No exposure code available.Titan touch pump, two cylinders and a reservoir were received for evaluation.The inlet tube with connector was detached to allow testing.Examination and testing of the returned components revealed a separation in the bladder of cylinder 2.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed it to be stretched.A group of striations, indicating contact with unshod instrumentation, was noted on the reservoir inlet tube.Testing revealed this to be a site of leakage.No functional abnormalities were noted with the pump, cylinder 2 or detached inlet tube with connector.Examination of the returned components revealed no abnormalities that would have contributed to the report of erosion or exposure.Quality accepts the physician's observations of such as the reason for surgical intervention.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the reservoir inlet tube occurred subsequent to the device packaging being opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or subsequent to explant.It was also concluded that the separation noted in the cylinder 1 bladder most likely occurred during sterilization post explant.These separations are not associated with the cause for failure.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.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 16CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9497741
• MDR Text Key: 172092727
• Report Number: 2125050-2019-01159
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539173
• UDI-Public: 05708932539173
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29162400
• Device Catalogue Number: ES2916
• Device Lot Number: 4684247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR