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

Model Number	ESR8202400
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
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, malfunction.Device removed and replaced.Additional info.From tm on (b)(6) 2020, "there also was not an obvious reason for the malfunction that i recall." 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 evaluation.Microscopic examination and testing of the returned components revealed partial separations within abrasion on each of the pump tubes.Testing revealed these to not be sites of leakage.Microscopic examination revealed confined abrasion on the reservoir inlet tubing at the tubing/strain relief junction.Testing revealed this to not be a site of leakage.Microscopic examination revealed surface abrasion on all pump tubing and pump strain reliefs, and cylinder 1 and cylinder 2 exhaust tubing.No functional abnormalities were noted with the pump, reservoir, cylinder 1 or cylinder 2.The information received indicated the device was malfunctioning, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.A review of the device history record confirmed that the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10806956
• Report Number: 2125050-2020-01071
• Device Sequence Number: 19670223
• Product Code: FHW
• UDI-Device Identifier: 05708932487566
• UDI-Public: 05708932487566
• Combination Product (Y/N): N
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 10/14/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/08/2020
• Supplement Report FDA Received Date: 05/07/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR