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

Model Number HUT EXT DR FINAL A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the system fluoro failed.Physician completed the procedure using endoscopy.Customer provided no further patient or procedural information, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Tech service troubleshot with biomed with reported error message (no camera images) and determined a possible camera cable issue.Biomed was trained on system and wanted to attempt the repair.Product monitoring followed up with biomed who reported, they were able to reseat the camera connections both at the image intensifier and on the back of the infimed tower.When system was rebooted, the no camera detected message was gone and there were no further reported issues.Possible loose camera connection.Service ticket was closed.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith rd.; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith rd.; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4095512
• MDR Text Key: 4832894
• Report Number: 1518293-2014-00104
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2014

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 FINAL A
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2007
• 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