MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number	ESR8202400
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the available information, the device leaked.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump, two cylinders and a reservoir were returned for evaluation.Examination and testing of the returned component revealed a separation with abrasion adjacent to it on the exhaust tube of cylinder 1.Testing revealed this to be a site of leakage.Partial separations within abrasion were noted on the shorter exhaust tube of the pump.Testing revealed these to not be sites of leakage.Abrasion was also noted on all tubes of the pump and strain relief of cylinder 2.No functional abnormalities were noted with the pump, cylinder 2 or reservoir.Based on examination of the returned product, it was concluded that while in-vivo the pump tubing overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to the exhaust tube of cylinder 1 kinking onto itself and abrading resulting in the separation noted.A separation of this type would then allow the loss of fluid, making the device inoperable.A review of the device history record no abnormalities and 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.

• Brand Name: (2BO)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: 8725232
• Report Number: 2125050-2019-00486
• Device Sequence Number: 19333971
• 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
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: ESR820
• Device Lot Number: 3773416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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
• Patient Age: 60 YR