MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29182400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/23/2018

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, titan touch was explanted due to a tubing issue.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan touch pump, reservoir, and two cylinders were received for evaluation.A small separation with a melted appearance was noted in the bladder of cylinder 1 near the base.Testing revealed this to be a site of leakage.Surface abrasion was noted on all tubes of the pump and cylinders.No functional abnormalities were noted with cylinder 2, the pump, or the reservoir.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.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 5022043.Because these components were released according to manufacturing and quality control procedures, quality concluded that the observed instrument separation in the bladder of cylinder 1 occurred subsequent to the device packaging being opened.In addition, because surfaces appear melted indicating contact with cauterizing instrumentation, and the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, quality concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.The information received indicated a tubing issue, but because no functional abnormalities were noted other than instrument damage, quality is unable to confirm the reported complaint.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7516019
• MDR Text Key: 108317218
• Report Number: 2125050-2018-00368
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539180
• UDI-Public: 05708932539180
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29182400
• Device Catalogue Number: ES29182400
• Device Lot Number: 5022043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR