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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP KERRISON RONGEUR, POWERED

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AESCULAP KERRISON RONGEUR, POWERED Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2017
Event Type  Injury  
Event Description
Neurosurgeon was using the number three kerrison instrument during a surgical procedure, a screw came loose on the kerrison and fell into the spinal cord. Neurosurgeon had to dig around in the opening with the suction and cst used a forcep to quickly grab it before it went into the neptune. No harm was done to the pt and instrument was reported.
 
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Brand NameKERRISON
Type of DeviceRONGEUR, POWERED
Manufacturer (Section D)
AESCULAP
MDR Report Key7112090
MDR Text Key94811435
Report NumberMW5073932
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/12/2017 Patient Sequence Number: 1
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