COOK UROCOGICAL STENT N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-02 for COOK UROCOGICAL STENT N/A manufactured by Cook Medical.

Event Text Entries

[7523] To or for removal of bilateral renal stents. Left ureteral stent broke off during removal attempt with alligator forceps. Approximately 2/3 of stent remains in patient. Right ureteral stent removed without incident. Stent implanted 5/27/93 a urological stent, multi-length silicone. Set #1491-358 #sfr. 22-23cm. Removal attempted 6/21/93. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, invalid data. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9843
• MDR Report Key: 9843
• Date Received: 1993-08-02
• Date of Report: 1993-06-25
• Date of Event: 1993-06-21
• Date Facility Aware: 1993-06-21
• Report Date: 1993-06-25
• Date Reported to Mfgr: 1993-06-21
• Date Added to Maude: 1995-02-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COOK UROCOGICAL STENT
• Generic Name: STENT
• Product Code: MER
• Date Received: 1993-08-02
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: 1491/358
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 9495
• Manufacturer: COOK MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-02