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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2023
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 perforator (id (b)(6)) during surgery.No adverse consequences for the patient.The drill used with the perforator was a midas (medtronic).According to information provided, it is unknown if the drill was electric or pneumatic, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.
 
Event Description
N/a.
 
Manufacturer Narrative
The perforator (id 261221) was returned for evaluation.Device history record (dhr)- no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye: unit was lightly soiled but had no other anomalies.Ifu (instructions for use) testing procedure was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release and the unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.Root cause analysis- the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The 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 Key17395973
MDR Text Key320164298
Report Number3014334038-2023-00117
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 09/07/2023
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? Yes
Device Operator Health Professional
Device Catalogue Number261221
Device Lot Number7009071
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/07/2023
Initial Date FDA Received07/26/2023
Supplement Dates Manufacturer Received09/01/2023
Supplement Dates FDA Received09/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
MIDAS (MEDTRONIC) DRILL
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