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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.
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DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Device Problem Failure to Auto Stop (2938)
Patient Problem No Code Available (3191)
Event Date 09/17/2013
Event Type  Injury  
Event Description
The medwatch report stated that while drilling burr holes with a midas rex drill with the codman perforator on, the perforator did not stop and the bit nicked the surface of the brain.The attending neurosurgeon controlled the bleeding and a new perforator drill bit was used to drill the remaining burr holes without further problems.
 
Manufacturer Narrative
It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information, it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time, this complaint is considered closed.Device not returned.
 
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Brand Name
DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key3585070
MDR Text Key20636767
Report Number1226348-2014-11175
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Report to Manufacturer01/14/2014
Date Manufacturer Received01/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age41 YR
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