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

Model Number N/A

Device Problem Melted (1385)

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

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported by the user facility that a patient underwent a robotic abdominal hysterectomy procedure using a bush ureteral illuminating catheter set.The attending physician indicated during the procedure the stent melted where the clear meets the black.No unintended sections of the device remain inside the patient¿s body nor did the patient experience any additional procedures or adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

Investigation - evaluation.A review of specifications was conducted during the investigation.The complaint device was not returned therefore physical examination of the device by the quality engineering and/or engineering departments could not be performed.A review of the device history record could not be performed since no lot number was provided.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: BUSH URETERAL ILLUMINATING CATHETER SET
• Type of Device: FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6310304
• MDR Text Key: 66776450
• Report Number: 1820334-2017-00184
• Device Sequence Number: 1
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 084120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 08/04/2017
• 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