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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

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INTEGRA LIFESCIENCES MANSFIELD 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 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 facility reported that during trepanation, the perforator (id 261221) did not disengage causing a dura mater tear.No clinical consequences for the patient.
 
Event Description
N/a.
 
Manufacturer Narrative
Perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - visual inspection utilizing the unaided eye performed.The unit was lightly soiled on the visible surface but was heavily soiled on the inside of the unit once the sleeve was removed.Unit also had a worn label.Spring test attempted, the inner / outer drill were fused and unit initially failed the spring test due to the very limited compression using downward force.A test hole was conducted to try and free the inner / outer but was unsuccessful.At this point the unit had the sleeve removed showing significant organic matter caked inside - this is likely the cause of the frozen inner / outer.The unit was then soaked in 70% ipa for 3 hours, and the organic material was removed.Once cleaned the unit was re-sleeved and passed the spring test as designed.Functional test performed once unit was re-sleeved and passed by successfully drilling 5 holes with no issues.In conclusion although the unit initially failed this was due to the "dried" organic matter freezing up the inner / out drill.The organic matter would not have frozen the drill at the time of surgery.Unit passed all tests post-cleaning therefore, the complaint could not be verified.Root cause remains undetermined.Product was received for analysis and the analyst could not confirm the complaint condition.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key16765812
MDR Text Key313558237
Report Number3014334038-2023-00050
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,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/07/2023
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 Number6899306
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/31/2023
Initial Date FDA Received04/18/2023
Supplement Dates Manufacturer Received06/09/2023
Supplement Dates FDA Received07/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2022
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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