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

Model Number ES88222400

Device Problems Inflation Problem (1310); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specification prior to release and 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 pump was not inflating.This was observed in (b)(6) 2020.The pump was replaced and it was noted the deflate mechanism failed, leaving one component in the bottom of the pump.

Manufacturer Narrative

This follow up mdr is created to document the evaluation of the returned device.A titan pump was the only component received for evaluation.Examination and testing of the returned component revealed the inner ball was loose inside the pump bulb.Microscopic examination revealed that the spring inside the exhaust strain relief area of the pump body was turned sideways.Based on examination of the returned pump, the loose ball inside the pump bulb was noted, confirming the reported complaint.However, quality is unable to determine how this may have occurred, as no further details were provided on the events that may have led up to the reported complaint.A great amount of force would be needed to dislodge the ball and move the spring inside the pump body.No further complaints of this nature have been reported for this lot number.A review of the device history record by quality engineering 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 number.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9996488
• MDR Text Key: 188901568
• Report Number: 2125050-2020-00359
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487269
• UDI-Public: 05708932487269
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES88222400
• Device Catalogue Number: ES8822
• Device Lot Number: 7007444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR