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

Model Number	ESR9162400
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.Lot number 3358224.
Event or Problem Description
According to available information, this device required replacement due to fluid loss.There was a hole in the tubing.No other adverse patient effects were reported.
Additional Manufacturer Narrative
A titan otr pump, two cylinders, and a reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.The surfaces of the detachment site of the longer exhaust tube of the pump appear to be rough and irregular, indicating stress was exerted.The surfaces of the detachment site of the exhaust tube of cylinder 1 appear to be rough and irregular, indicating stress was exerted.No functional abnormalities were noted with cylinder 2.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.While no functional abnormalities were noted during testing with the returned components, microscopic examination of the surfaces of the exhaust tube detachment end between the pump and cylinder 1 revealed rough and irregular surfaces, indicating stress was exerted.Based on the overlapping of the pump tubes, in combination with device usage over time, this could contribute to sufficient stress to separate the exhaust tubing of the pump.A separation of this type would then allow the loss of fluid, making the device inoperable.

• Brand Name: TITAN OTR
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 17059995
• Report Number: 2125050-2023-00699
• Device Sequence Number: 8577581
• Product Code: FHW
• UDI-Device Identifier: 05708932487641
• UDI-Public: 05708932487641
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ESR9162400
• Device Catalogue Number: ESR916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male