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

Model Number 404008

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: guerbet's tech support received a call from a hospital technician who reported that, during a procedure, they raised the table of their hydra vision urology system.After reaching its 'up' most position, the table got stuck and would not respond to the hand or foot switch.The procedure was completed as planned with no risk or injury to the patient or care giver.To assist the technician in identifying possible causes of the stuck table, tech support instructed the technician to pull down on the splash cover to insure that the limit switch was not obstructed.Additionally, tech services advised the technician to power-cycle the table, which the technician did after the procedure.By power-cycling the table, the technician was able to lower the table normally, and remove the patient.In a later tech service follow-up call, the operating room director stated that by power-cycling the system, it became fully functional, and as remained in this condition since, and that there was no need to have a field service engineer visit to examine the system.System remained in full service.Root/probable cause code: equipment/instrument - failure.Root/probable cause summary: refer to investigation summary.Since a power-cycle returned the system to fully operational, the root cause is unknown, and no further investigation is required at this time.A review of guerbet's complaint tracking system showed no similar issues with this device.No capa required at this time, qa will continue to monitor and trend such issues during quality metrics and management reviews for additional corrective action consideration.Disposition summary: unit remained in full service.

Event Description

This incident was reported on (b)(6) 2019 as reporter states that there was patient on the table, and that the team put the table all the way up, and at the time of the call, the table would not go back down.The reporter states that there was a patient on the table at the time of the call, and that they had the table all the way up elevation and the table will not lower with the hand or foot switch.Call receiver states that he had the reporter try and grab the splash crash cover and pull down on it in case a splash crash micro switch was stuck, which would cause this symptom.Reporter stated that she was not successful, and that they would finish the case and will try and remove the patient from the table elevated.Reporter states that there was no injury to patient or staff.On follow-up call with the facility, the operating room director stated that the issue was resolved the same day that it occured.The director states that they did not want to cycle power on the table during the procedure, so they finished the patient case first.The director states that when the patient case was complete they cycled power on the table and the table would then lower so that they could easily take the patient off the table.The table has had no issue since and they do not request service to come to the site.

• 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 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, OH 45237
• MDR Report Key: 8429015
• MDR Text Key: 139431681
• Report Number: 1518293-2019-00005
• 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: consumer,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1