MAUDE Adverse Event Report: COOK UROLOGICAL INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G49977
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that prior to the procedure, a small tear was found on the ureteral stent.It was further noted that the stent was torn starting at the first side-port and stopped before going through the tip.The customer used another device to complete the procedure and no patient harms were reported.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• MDR Report Key: 7424734
• Report Number: 1820334-2018-01064
• Device Sequence Number: 18881136
• Product Code: FAD
• UDI-Device Identifier: 10827002499772
• UDI-Public: (01)10827002499772(17)160201(10)U2313266
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: G49977
• Device Catalogue Number: USH-600-R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1