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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC CODMAN NEUROSURGICAL PADDLE

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CODMAN & SHURTLEFF, INC CODMAN NEUROSURGICAL PADDLE Back to Search Results
Model Number 24-5404
Device Problems Material Separation (1562); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2018
Event Type  Injury  
Event Description
Cottonoid sponges (aka surgical patties) had been used during spinal surgery. These cottonoids are 1/2 x 1/2 inch with a long floss-like tail on them. There is a radiopaque strip on the cottonoid. While inserting the spinal cage with a mallet, we believe that two cottonoid sponges got separated from the strings that are attached to it. A single string was found in the surgical field, which alerted the surgeon to look for a cottonoid that it was attached to. A cottonoid without a string was found and thought to be the cottonoid that would attach to the string. They believe that the edges of the spinal cage may have been sharp enough to separate the string from the cottonoid. However, the count was off by one cottonoid despite this one being found. The room was searched, the floor, the bottom of the staff members shoes, the drapes, the wheels of the table/stretcher/iv poles etc. No cottonoid was found. As per policy, an x-ray was done of the surgical site prior to the patient leaving the operating room suite, including a pa and lateral. No cottonoid was seen on x-ray despite being reviewed by two radiologists and the surgeon. The patient was closed and brought to his room. The patient, who had been having drainage at the site, had a ct-scan which indicated that there may be a retained cottonoid. A few days later the patient was brought back to surgery where the cottonoid was found, however no string was attached to the cottonoid. The strings of these cottonoids are not radiopaque. As the risk manager, there is concern that this string can become detached from the radiopaque patty. However, the string is not radiopaque and therefore cannot be found on x-ray.
 
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Brand NameCODMAN
Type of DeviceNEUROSURGICAL PADDLE
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC
325 paramount dr.
raynham MA 02767
MDR Report Key8284429
MDR Text Key134327679
Report Number8284429
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24-5404
Device Catalogue Number24-5404
Device Lot NumberHU9483
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2019
Event Location Hospital
Date Report to Manufacturer01/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/29/2019 Patient Sequence Number: 1
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