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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

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RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Model Number 261221
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem Brain Injury (2219)
Event Date 04/24/2023
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported disengagement failure of a perforator ((b)(4)) during surgery, causing dural damage and a minor brain contusion.Dural reconstruction was performed, and the event led to surgical delay of less than 30 minutes.The procedure was completed with a replacement product available.The manufacturer of the drill is a primado/nakanishi.According to information provided, it is unknown if the perforator clicked in place with the drill, or if the recommended spring tests were performed between each burr hole.It is also unknown if the angle approach was perpendicular as the ifu (instructions for use) states, and if there was constant downward pressure.
 
Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Perforator (id 261221) has been returned for evaluation.Device history record (dhr)- there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a visual inspection showed that the unit was lightly soiled with organic material, but no other anomalies were observed.Unit passed spring test and functioned as designed.Functional test performed and the unit successfully drilled 5 holes with no issues and functioned as designed.Root cause - product was received for analysis and the analyst could not confirm the complaint condition.Possible root cause per the failure analyst ¿user misuse or drill allows to be set incorrectly".
 
Event Description
N/a.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key16895397
MDR Text Key314827840
Report Number3014334038-2023-00065
Device Sequence Number1
Product Code HBF
UDI-Device Identifier10381780513599
UDI-Public10381780513599
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number261221
Device Catalogue Number261221
Device Lot Number6899373
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/25/2023
Initial Date FDA Received05/09/2023
Supplement Dates Manufacturer Received07/13/2023
Supplement Dates FDA Received07/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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