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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 Insufficient Information (4580)
Event Type  malfunction  
Event Description
A facility reported a perforator failed to disengage.No additional information has been provided.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
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 - a visual inspection was performed and observed that the unit was lightly soiled and had a worn label, but no other anomalies.A spring test was performed, and the unit passed as designed.A functional test was performed, the unit successfully drilled 5 holes with no issues and functioned as designed.Unit passed all functional tests.Therefore, the complaint condition could not be confirmed.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.¿.
 
Event Description
N/a.
 
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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 Key16894705
MDR Text Key314818882
Report Number3014334038-2023-00066
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,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/13/2023
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 Number6666856
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/24/2023
Initial Date FDA Received05/09/2023
Supplement Dates Manufacturer Received06/28/2023
Supplement Dates FDA Received07/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2022
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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