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 Type  Injury  

Event Description

A universa firm ureteral stent set was placed in the physicians 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.

Manufacturer Narrative

During investigation, a review of complaint history, drawing, instructions for use (ifu), manufacturing instructions (mi) and quality control (qc) was conducted as the product was not returned, no physical evaluation of the device could be completed the ureteral stent was placed in the patient in the 0 r at an unknown date and removed within the physicians clinic at an also unknown date.During its removal, the stent lost its tether.The stent was removed per cystoscopy in the 0 r it is possible that the user exerted too much force while removing the stent.However, based on the information provided, the root cause is undetermined due to the insufficient risk, there will be no corrective actions taken at this time the risk for this failure mode has been assessed using quality reengineering risk assessment.There is no evidence to suggest this product was not manufactured to current specifications.The patient did not have any adverse effects as a result of this event.There is no evidence to suggest that the product was not manufactured to specifications.Quality engineering risk assessment was used to assess the risk of this complaint per the conclusion, no further risk reduction is required.The appropriate internal personnel have been notified and monitoring for similar complaints will continue.

Event Description

The stent was placed in the patient in the operating room at an unknown date and removed within the physician's clinic at an also unknown date.During its removal, the stent lost its tether.The stent was removed per cystoscopy in the operating room.The patient did not have any adverse effects as a result of this event.

• 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 ; po box 227; spencer, IN 47460 ; 8123392235
• MDR Report Key: 3981158
• MDR Text Key: 4887879
• Report Number: 1820334-2014-00318
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Catalogue Number: UFH-524-RT1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 07/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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