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

Model Number	ESR8202400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
According to the available information, though not verified, this was a revision of a coloplast otr.The implant being removed had a tube fracture just above the pump.Also when removing damaged ipp one of the rear tips came off and was stuck in the right corporal body.The use of a flexible cystoscope was needed to locate and remove.Device removed and replaced.Additional information received (b)(6) 2021: the hospital said they will return it, but they had a process to follow first.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
Additional Manufacturer Narrative
A titan otr pump, two cylinders, and a reservoir were received for analysis.A separation within abrasion was noted on the longer exhaust tube of the pump.Testing revealed this to be a site of leakage.Partial separations within abrasion were noted on the inlet tube of the pump.This was not a site of leakage.Abrasion was also noted on the shorter exhaust tube of the pump.Abrasion was noted on both cylinder exhaust tubes.No functional abnormalities were noted with cylinders 1 or 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.This positioning, in combination with device usage over time, may contribute to sufficient stress(s) to separate the longer exhaust tubing at this site.A separation of this type could then allow the loss of fluid, making the device inoperable.D4: lot number: 3842850.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11255602
• Report Number: 2125050-2021-00092
• Device Sequence Number: 3649007
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESR8202400
• Device Catalogue Number: ESR820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 01/30/2021
• Supplement Report FDA Received Date: 06/30/2021
• Patient Sequence Number: 1
• Patient Age: 67 YR