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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 Insufficient Information (4580)
Event Date 08/18/2022
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
This is 2 of 2 reports linked to mfg report numbers: 3014334038-2022-00198.A physician reported disengagement failure of a codman disposable perforator (id 261221).It occurred at making the third and the fourth burr holes at the tent.When making the fifth burr hole, the device was changed to another one.A pneumatic midas rex (medtronic) was used with the perforator.According to reporter, 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.
 
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 - unit was soiled with organic matter, after being cleaned unit passed all tests to meet acceptance criteria.Unit pass the test for function.Visual inspection, revealed unit was heavily soiled with organic matter unit and pass after cleaning.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.Although the complaint was not confirmed, root cause was investigated using the risk documentation and potential causes of failure include: user misuse.
 
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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 Key15627859
MDR Text Key307074944
Report Number3014334038-2022-00238
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 12/07/2022
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 NumberX369810
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/03/2022
Initial Date FDA Received10/18/2022
Supplement Dates Manufacturer Received11/21/2022
Supplement Dates FDA Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2022
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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