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

Model Number	ESR8202400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
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.The device has been received at coloplast; however the evaluation is not yet complete.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.
Event or Problem Description
According to the available information, crack in clear tubing coming from the pump.Device was removed and replaced.
Additional Manufacturer Narrative
A titan otr, two cylinders, and reservoir were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion in the exhaust tubing of cylinder 2.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.Three separations were also noted in the reservoir strain relief.Testing revealed these to be sites of leakage.Microscopic examination of the surfaces revealed that one of the separations was rough and irregular, indicating stress was exerted.The other two separations displayed smooth and straight surfaces, indicating contact with sharp instrumentation.Partial separations, within abrasion were also noted in the exhaust tubing of cylinder 2.Testing revealed these to not be sites of leakage.The presence of surface abrasion was noted on both pump exhaust tubing, the reservoir inlet tubing, and on the exhaust tubing of cylinder 2.Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with the separation of the exhaust tubing of cylinder 2 and on the strain relief separation that exhibited rough and irregular surfaces indicates that sufficient stress(s) was exerted on the tubing and on the strain relief to separate these sites while in-vivo.Separations of this type would then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release and no anomalies were noted during production.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN OTR
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10169542
• Report Number: 2125050-2020-00460
• Device Sequence Number: 11603354
• 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 Implanted Year: 2013
• 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): 07/28/2020

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: Lay User/Patient
• Device Model Number: ESR8202400
• Device Catalogue Number: ESR820
• Device Lot Number: 3634110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR