MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD

Model Number 404008

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591); Failure to Shut Off (2939)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 07/13/2020

Event Type  malfunction  

Event Description

This incident was reported by the facility on 20 july 2020.This incident occurred on (b)(6) 2020.Incident: the surgeon was preforming a left ureteroscopy with laser lithotripsy and stent placement in or room 7 (cysto).They called company fse and stated they were having trouble with the machine.When fse got over to the room, fse was told that the surgeon had taken his foot off the exposure petal and the machine kept exposing.They had turned off the table generator and the nurse present reported that the machine continued to expose.They contacted another rn, who came in and turned off the exposure panel/computer prior to fse arrival.They had successfully had taken multiple images but the last 3 images were black and there was no body part 4.0 minutes but the last 3 images were black and there was no body part.4.0 minutes of fluoroscopy was used.Dose of 12.98 mgy was used.Fse turned the room back on and there was error code of "error 15", "ii not extended", "collimation".Fse checked the tube was fully extended but the remote would not move the tube even with the enable button placed.The generator computer was flashing "fault alarm reset" and would not stop flashing and beeping.Fse was not able to do anything with the machinery.I turned it off again and got a portable machine for the final image of the patient.Summary: while surgeon was performing an x-ray on the patient during a ureteroscopy, he let his foot off the pedal and it continued to x-ray.Rn moved pedal around and off a cord briefly, which did not resolve the issue.Rn then pressed red emergency button on machine, it did not stop.Button pushed on other side of machine it still did not stop.Rn went to back room to asses monitor.It showed there was continuing exposure along with alarm.Call to charge rn and x-ray to come and assist.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati, oh
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, oh
• MDR Report Key: 10393459
• MDR Text Key: 217456464
• Report Number: 1518293-2020-00014
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1