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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN DISOPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC

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CODMAN & SHURTLEFF CODMAN DISOPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC Back to Search Results
Catalog Number 26-1221
Device Problem Split (2537)
Patient Problem Injury (2348)
Event Date 05/23/2014
Event Type  Injury  
Event Description
The sales rep reported: situation : perforator was attached to a medtronic midas rex drill.Codman perforator did not disengage and then split into two pieces.Perforator penetrated the brain by 4mm.Surgery was delayed appx 30 minutes.Patient is currently stable.
 
Manufacturer Narrative
Upon completion of investigation, a follow up report will be filed.
 
Manufacturer Narrative
Complaint is currently being investigated under (b)(4) by supplier.The investigation takes 30 days with an anticipated completion date of 7/16/14.Once the investigation report is completed the complaint will be re-opened and updated accordingly.Device is under investigation.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the supplier evaluation was received on 7/25/14, there evaluation is as follows:the root cause for the reported problem was not determined.The functional test was not performed (refer to functional test below); therefore, the customers¿ complaint "codman perforator did not disengage", could not be confirmed.There have been no previous customer complaints on perforators from lot dg0225.Functional test: a manual operation and disengagement test (based on the procedure described in the ifu), and a functional test, were not performed.It was judged that the extent and locations of the nicked edges and surfaces observed on the drill body could affect the proper function of the perforator.Dimensional inspections were also not performed due to the extensive damage observed on the drill body.A device history records review as performed and revealed that all tests and inspections associated with the assembly process, met specification requirement.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.
 
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Brand Name
CODMAN DISOPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC
Manufacturer (Section D)
CODMAN & SHURTLEFF
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key3879556
MDR Text Key15181479
Report Number1226348-2014-11711
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/01/2019
Device Catalogue Number26-1221
Device Lot NumberDG0226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/28/2014
Initial Date FDA Received06/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/22/2014
07/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2014
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;
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