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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2023
Event Type  malfunction  
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 disposable perforator (id (b)(6)) during surgery.It occurred at making the first burr hole at the tent.Since it was used without pressing, it was said that it did not lead to damage to the dura mater.The procedure was completed with a replacement product available.Surgical time was extended less than 30 minutes.The patient recovered.The manufacturer of the drill used with the perforator was bien air/yufu.According to information provided, it is unknown if the drill was electric or pneumatic, and it is unknown if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.In addition, it is unknown if the perpendicular approach maintained through the drilling process or if there was any rocking motion included, and also unknown if there was constant downward pressure.
 
Manufacturer Narrative
The codman disposable perforator (id 261221) was 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 was performed utilizing the unaided eye, unit was lightly soiled and had a partially worn eo label.A spring test was performed, unit passed the spring test and functioned as designed.Functional test performed, unit successfully drilled 5 holes with no issues.Therefore, the complaint condition could not be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.However, the possible root cause is: ''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 Key16732423
MDR Text Key313317493
Report Number3014334038-2023-00048
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 05/18/2023
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? Yes
Device Operator Health Professional
Device Model Number261221
Device Catalogue Number261221
Device Lot Number6910170
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/27/2023
Initial Date FDA Received04/13/2023
Supplement Dates Manufacturer Received05/10/2023
Supplement Dates FDA Received05/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age59 YR
Patient SexFemale
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