MAUDE Adverse Event Report: COOK INCORPORATED BUSH URETERAL ILLUMINATING CATHETER SET; LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL

Lot Number 6998468

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2016

Event Type  malfunction  

Event Description

During a surgical procedure, a ureteral laminating stent was plugged into light source and after 15 to 20 seconds after being plugged in, staff noted smoke coming out of the light source hole above where the stent was plugged into.Surgeon stated unable to see stent lighted and surgeon started to unplug it.After turning off, smoke came out of both holes where it was unplugged.Staff person reported visually saw bright red center at end of stent where it was plugged into light source.Biomed noted event as "unit smoked when user connected ureteral illuminating catheter set.Cook medical; lot #6998468; ref # (b)(4).Tech was able to duplicate the problem when he connected the catheter to the light source.Unit worked ok with other head set.Contacted manufacturer and reported the problem and a representative picked up the catheter for an investigation.In follow up to the investigation, cook reported that there was no indication that a design or process related failure mode contributed to the event a definitive root cause could not be established.

• Brand Name: BUSH URETERAL ILLUMINATING CATHETER SET
• Type of Device: LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6263152
• MDR Text Key: 65245255
• Report Number: 6263152
• Device Sequence Number: 0
• Product Code: FCS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 6998468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE LIGHT SOURCES MANUFACTURER - LUXTEC, MODEL 930
• Patient Age: 35 YR