MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89222400

Device Problems Break (1069); Material Separation (1562); Pumping Problem (3016)

Patient Problem No Information (3190)

Event Date 09/10/2019

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, the pump malfunctioned.A break was reported.The device was explanted and replaced with another inflatable device.

Manufacturer Narrative

This follow up mdr is created to document the conclusion of the investigation.A titan pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation on the posterior side of the pump body at the top of the exhaust tube strain reliefs.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be smooth and non-striated, indicating stress was exerted.Abrasion was noted on the shorter exhaust tube and inlet tube of the pump.No functional abnormalities were noted with either cylinder.Based on examination of the returned product, it was concluded that while in-vivo both the shorter exhaust tube and inlet tube of the pump had overlapped and abraded against one another.The smooth, non-striated surfaces of the separation indicated that sufficient stress may have been exerted on the pump body to separate the site while in-vivo.The information received the device was implanted over a year, but additional information regarding the reported complaint was not provided.Therefore, quality is unable to determine the cause of the separation.A separation of this type could allow the loss of fluid, making the device inoperable.A review of the device history record by a quality engineer 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.

Event Description

Additional information and picture/video received indicated a separation on the posterior side of the pump body near the exhaust strain relief area.

• Brand Name: TITAN SCROTAL ZERO ANG 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9176555
• MDR Text Key: 161962288
• Report Number: 2125050-2019-00859
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487382
• UDI-Public: 05708932487382
• 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
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89222400
• Device Catalogue Number: ES8922
• Device Lot Number: 6287830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR