MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number	ESR8202400
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, device malfunction.
Additional Manufacturer Narrative
A titan otr pump, two cylinders, and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation at the exhaust tube/strain relief junction of cylinder #2.Testing revealed this to be a site of leakage.The separation appears to be rough and irregular, indicating sufficient stress was exerted.Surface abrasion is noted on all tubes of the pump and the strain relief of the longer exhaust tube and inlet tube of the pump, and on the inlet tube of the reservoir.No functional abnormalities are noted with cylinder #1 or the reservoir.Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted at the exhaust tube/strain relief junction of cylinder #2 to separate the site while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.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 OTR INFRA ZERO ANG
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7105977
• Report Number: 2125050-2017-00616
• Device Sequence Number: 16511981
• Product Code: FHW
• UDI-Device Identifier: 05708932487566
• UDI-Public: 05708932487566
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ESR8202400
• Device Catalogue Number: ESR8202400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other