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

Model Number	5177801400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
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.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, titan otr was explanted due to break in tubing.
Additional Manufacturer Narrative
A titan otr pump, two cylinders, and piece of detached inlet tubing were received for evaluation.Examination and testing of the returned components revealed a separation near the strain relief on the longer exhaust tube of the pump.Testing revealed this to be a site of leakage.The separation appears to be rough and irregular, indicating sufficient stress was exerted.Partial separations are noted on the inlet tube of the pump.Testing revealed these not to be sites of leakage.Surface abrasion is noted on all tubes and all strain relief of the pump.A group of striations are noted on the exhaust tube of cylinder #1, indicating contact with unshod instrumentation.Testing revealed these not to be sites of leakage.A partial separation is noted on the exhaust tube of cylinder #1.Testing revealed this not to be a site of leakage.No functional abnormalities are noted with cylinder #1, cylinder #2, or the detached inlet tubing.Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted on the longer exhaust tube of the pump to separate the site while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

• Brand Name: PUMP OTR
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7428386
• Report Number: 2125050-2018-00293
• Device Sequence Number: 13943798
• Product Code: FHW
• UDI-Device Identifier: 05708932319744
• UDI-Public: 05708932319744
• 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: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5177801400
• Device Catalogue Number: 5177801400
• Device Lot Number: 1654166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR