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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC MIRA-I CS RETRACTOR SYSTEM, COMPLETE; CLAMP-LESS BEATING HEART
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MAQUET CARDIOVASCULAR, LLC MIRA-I CS RETRACTOR SYSTEM, COMPLETE; CLAMP-LESS BEATING HEART Back to Search Results
Model Number MS-1000
Device Problem Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2014
Event Type  malfunction  
Event Description
The hospital reported that after sterilization, there was color bleeding from the blades of the mira-i cs retractor system, complete.The device would not pivot properly and they felt like it was bent in the jaws.The hospital reported no pt effects.
 
Manufacturer Narrative
The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
 
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Brand Name
MIRA-I CS RETRACTOR SYSTEM, COMPLETE
Type of Device
CLAMP-LESS BEATING HEART
Manufacturer (Section D)
MAQUET CARDIOVASCULAR, LLC
wayne NJ
Manufacturer (Section G)
MAQUETER CARDIOVASCULAR, LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4349399
MDR Text Key5201942
Report Number2242352-2014-01370
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMS-1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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