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

Catalog Number UFH-524-RT1

Device Problem Malfunction (2409)

Patient Problem Foreign body, removal of (2365)

Event Date 06/17/2014

Event Type  Injury  

Event Description

Universal firm ureteral stent set was placed in patient in the physician's clinic.The stent lost tether and took out strut cystoscopy in operating room.It was not provided by the physician how the procedure was completed.No harm to the patient and no additional procedures were needed.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: rita harden, director ; p.o. box 227; spencer, IN 47460 ; 8123392235
• MDR Report Key: 3981123
• MDR Text Key: 4633079
• Report Number: 1820334-2014-00319
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: UFH-524-RT1
• Device Lot Number: U2478318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2014
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention