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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDURE MEDICAL, INC. LUXOR OPHTHALMIC MICROSCOPES; MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
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ENDURE MEDICAL, INC. LUXOR OPHTHALMIC MICROSCOPES; MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC Back to Search Results
Model Number E-71
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that the screw on the side that stops the microscope head from going up or down came off before surgery.
 
Manufacturer Narrative
The company service representative examined the system and confirmed the reported event.The company service representative reinstalled the screw and adjusted the entire locking assembly to resolve the issue.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event is unable to be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
LUXOR OPHTHALMIC MICROSCOPES
Type of Device
MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
Manufacturer (Section D)
ENDURE MEDICAL, INC.
1455 ventura dr
cumming GA 30040
MDR Report Key8414451
MDR Text Key138906819
Report Number2028159-2019-00404
Device Sequence Number1
Product Code HRM
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberE-71
Device Catalogue Number8065752239
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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