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

Model Number ES29161022

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

Quality was unsuccessful in securing the explanted prosthesis for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 4413946.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

Event Description

According to the available information, malfunction, tubing leakage.Additional information indicated a tear in the pump exhaust tubing.

Manufacturer Narrative

This follow up mdr is created to document the evaluation of the returned device.A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the exhaust tube of cylinder 1 near the strain relief.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.No functional abnormalities were noted with the pump or cylinder 2.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted on the exhaust tube of cylinder 1 near the strain relief to separate the site while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.

• 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: 7948013
• MDR Text Key: 123115913
• Report Number: 2125050-2018-00726
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29161022
• Device Catalogue Number: ES2916
• Device Lot Number: 4413946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR