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

Model Number	ESR9162400
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/15/2019
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, pump would not inflate cylinders.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation at the cylinder 1 cylinder bladder/base junction due to delamination.Testing revealed this to be a site of leakage.Abrasion was noted on both exhaust tubes of the pump and exhaust tube of cylinder 2.No functional abnormalities were noted with pump or cylinder 2.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes of the pump had overlapped and abraded against one another.This positioning, in combination with device usage over time, may have contributed to sufficient stress(s) to separate the cylinder bladder from the base on cylinder 1.A separation of this type would then allow the loss of fluid, making the device inoperable.A review of the device history record 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 SCROT ZERO ANG
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050 ; DA 3050
• MDR Report Key: 8524334
• Report Number: 2125050-2019-00269
• Device Sequence Number: 14049425
• Product Code: FHW
• UDI-Device Identifier: 05708932487641
• UDI-Public: 05708932487641
• 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): 07/16/2019

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: ESR9162400
• Device Catalogue Number: ESR916
• Device Lot Number: 3662619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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: 75 YR