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U.S. Department of Health and Human Services

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

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LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE Back to Search Results
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.
 
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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 Key4095512
MDR Text Key4832894
Report Number1518293-2014-00104
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 NumberHUT EXT DR FINAL A
Device Catalogue Number404007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/18/2014
Initial Date FDA Received09/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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