MAUDE Adverse Event Report: COOK MEDICAL BUSH SL URETERAL LIGHTED CATHETER SET

Model Number J-BICS-058020

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 08/05/2015

Event Type  malfunction  

Event Description

Pt developed small blister on his leg after wires connecting the lighted ureteral stents burned into two pieces during a surgical procedure.

• Brand Name: BUSH SL URETERAL LIGHTED CATHETER SET
• Type of Device: BUSH SL URETERAL LIGHTED CATHETER SET
• Manufacturer (Section D): COOK MEDICAL ; bloomington IN 47404
• MDR Report Key: 5001520
• MDR Text Key: 22998527
• Report Number: MW5055364
• Device Sequence Number: 1
• Product Code: FCS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: J-BICS-058020
• Device Catalogue Number: G16737
• Device Lot Number: 5798210
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 100