MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES89142400
Medical Device Problem Code	Mechanical Problem (1384)
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 or 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, malfunction.
Additional Manufacturer Narrative
A titan otr pump and two cylinders were received for analysis.A small area of confined abrasion was noted on the longer exhaust tube of the pump at the tube/strain relief junction.The detachment end of the shorter exhaust tube revealed the surfaces to be rough and irregular, indicating stress was exerted.Foreign material (i.E.Dried tissue) was noted in the inlet tube of the pump.Due to the foreign material, not all testing could be completed.Partial separations within abrasion were noted on the exhaust tube of cylinder 1.This was not a site of leakage.The detachment end of the exhaust tube of cylinder 1 showed surfaces to be rough and irregular.Abrasion was also noted on the exhaust tube of cylinder 2.No functional abnormalities were noted with cylinder 2.Based on examination of the returned product, both cylinders and some of the pump testing passed functional testing.There was a piece of foreign material (i.E.Dried tissue) inside the pump inlet tube which did not allow all testing of the pump to be completed.However, microscopic examination of the detachment end of the shorter exhaust tube of the pump and exhaust tube of cylinder 1 revealed the surfaces to be rough and irregular, indicating stress may have been exerted on the exhaust tube to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.As the information received only notes "malfunction", and because no other functional abnormalities were noted during testing, quality concludes the rough and irregular detachment through the shorter exhaust tube of the pump and cylinder 1 may have been the site of failure.A separation in the tubing may then allow tissue to be introduced into the tubing, as noted in the pump inlet tube.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: TITAN SCROTAL ZERO ANG 14CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 8761197
• Report Number: 2125050-2019-00530
• Device Sequence Number: 2296281
• Product Code: FHW
• UDI-Device Identifier: 05708932487306
• UDI-Public: 05708932487306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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: ES89142400
• Device Catalogue Number: ES8914
• Device Lot Number: 3670913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male