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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

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CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Catalog Number 26-1221
Device Problem Failure to Auto Stop (2938)
Patient Problem Tissue Damage (2104)
Event Date 10/25/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Upon completion of the investigation a follow up report will be filed.
 
Event Description
It was reported that the injury to the dura occurred when the surgeon used the perforator to open the burr hole.The product was not re-sterilized and used for this procedure.The product will be returned to your site.Per affiliate: "the injury to the dura occurred when the surgeon used the perforator to open the 1st burr hole.It was at right orbital floor tumor is excised.It has the same hole as the rotation of cutting part.The dural suture was performed.There was 2 drills were in the site.The issue occurred with #1 drill.The drill was replaced with #2 drill and the procedure was completed without any problem.Cerebrospinal fluid leak does not occur, and the patient is under observation.".
 
Manufacturer Narrative
The affiliate was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.We will continue to monitor for this or similar complaints for this product code.The lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.No further action is required.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7041071
MDR Text Key92347746
Report Number1226348-2017-10855
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,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 Catalogue Number26-1221
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/26/2017
Initial Date FDA Received11/17/2017
Supplement Dates Manufacturer Received11/28/2017
Supplement Dates FDA Received12/12/2017
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 Age68 YR
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