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

Model Number ESR9222400

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.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.

Event Description

According to the available information, cracked tubing at pump was reported.The implant was replaced with another device.

Manufacturer Narrative

A titan otr pump, two cylinders, and a reservoir were received for analysis.Partial separations within abrasion were noted on the longer exhaust and inlet tubing of the pump.These were not sites of leakage.A separation, adjacent to a confined area of abrasion, was noted in the exhaust tube of both cylinders 1 and 2 near the tube/strain relief junction.These were both sites of leakage.Partial separations with in abrasion were noted on both cylinder exhaust tubes.These were not sites of leakage.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the abrasion marks noted on the both exhaust tubing and inlet tubing of the pump matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.This then may have caused the exhaust tube of cylinders 1 and 2 to be kinked onto themselves for a period of time.This positioning, in combination with device usage over time, may contribute to sufficient stress(s) to separate the cylinder exhaust tubing at these sites.Separations of this type could then allow the loss of fluid, making the device inoperable.Review of lot # for complaint trend, nonconforming report and capa review.No trends noted.

• Brand Name: TITAN OTR SCROT ZERO ANG
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9571974
• MDR Text Key: 174533360
• Report Number: 2125050-2020-00016
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487702
• UDI-Public: 05708932487702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ESR9222400
• Device Catalogue Number: ESR922
• Device Lot Number: 3470914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male