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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
Catalog Number 261221
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problems Brain Injury (2219); No Clinical Signs, Symptoms or Conditions (4582)
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.The dura was reconstructed.According to information provided, the manufacturer of the drill is midas and it is unknown whether it was electric or pneumatic.It was also unknown if the perforator clicked in place in the drill.The recommended spring test were performed between each burr hole, and angle of approach was perpendicular as the ifu states.It is unknown if the perpendicular approach was maintained through the drilling process or a rocking motion included.It is unknown if there was constant downward pressure.
 
Manufacturer Narrative
Additional information received: brain contusion was also observed.
 
Event Description
N/a.
 
Manufacturer Narrative
Perforator (id: 261221) has been returned for evaluation.Unique device identification (udi): (b)(4).Failure analysis - a visual inspection utilizing unaided eye and noted that the unit has significant tooling on the od and was potentially autoclaved.Spring test was performed and the unit passed the spring test and functioned as designed.A functional test was performed, the unit drilled 5 holes with no issues and functioned as designed.Therefore, the complaint condition could not be verified.Root cause - root cause remains undetermined.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.
 
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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 Key16854290
MDR Text Key314391117
Report Number3014334038-2023-00058
Device Sequence Number1
Product Code HBF
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,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 Catalogue Number261221
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/11/2023
Initial Date FDA Received05/02/2023
Supplement Dates Manufacturer Received05/18/2023
07/13/2023
Supplement Dates FDA Received06/09/2023
07/20/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
MIDAS DRILL.
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