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

Model Number HUT EXT DR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during a urology cystoscopy, for stent placement the system would not fluoro.Physician completed the procedure using endoscopy.Customer provided no further procedural or patient details, other than to say patient is fine.No reported injury.

Manufacturer Narrative

Field service engineer (fse), based on what was described as the problems, had a new fluoro footswitch and an atp console board shipped to site.Fse arrived on site, investigated the generator interface malfunction issue, but was not able to duplicate the alarm message (the atp console board was not needed).Fse replaced the fluoro footswitch tested for correct operation and verified system operation according to service checklist (b)(4).Unit passed checkout procedures and was returned to the customer for service.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith road; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith road; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4543539
• MDR Text Key: 19763271
• Report Number: 1518293-2015-00009
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2015

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: HUT EXT DR
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 02/25/2015
• 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: Reuse
• Patient Sequence Number: 1