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

Model Number ES29181022

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release and no trends were noted.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, pump tubing leak (tear).The device was revised.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received though not verified, indicated a tear of the pump tubing.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

Event Description

A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the longer pump exhaust tubing at the tubing/strain relief junction.Testing revealed this to be a site of leakage.Microscopic evaluation revealed surface abrasion, indicating repetitive contact between surfaces.Microscopic evaluations revealed surface abrasion on all pump tubing, indicating repetitive contact between surfaces.No functional abnormalities were noted with cylinder 1 or cylinder 2.Based on examination of the returned product, it was concluded that the abrasion marks noted on all pump tubing may have overlapped and abraded against one another while in-vivo.This positioning, in combination with device usage over time, may have contributed sufficient stress(s) to cause a separation of the longer pump exhaust tubing at the tubing/strain relief junction.A separation of this type could then allow the loss of fluid, rendering the device inoperable.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10427118
• MDR Text Key: 203720291
• Report Number: 2125050-2020-00733
• 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,Followup
• Report Date: 08/05/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: ES29181022
• Device Catalogue Number: ES2918
• Device Lot Number: 4860623
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 07/21/2020
• Supplement Dates FDA Received: 09/30/2020; 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR