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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 Failure to Auto Stop (2938)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
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 during surgery.It occurred during the first burr hole, the physician made a total of three burr holes.It is unknown if there was patient injury or surgical delay.
 
Manufacturer Narrative
The perforator (261221) was returned for evaluation: failure analysis - the perforator unit was inspected using the unaided eye.Unit was lightly soiled from surgery and had partially worn label that could not be read.No other anomalies were observed.Ifu testing was performed per procedure with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.Root cause - product was received for analysis and the investigation could not confirm the complaint.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A trending and risk assessment were performed as part of the evaluation.The risk remains acceptable per the risk analysis.
 
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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
MDR Report Key11600168
MDR Text Key256758024
Report Number3014334038-2021-00062
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
Type of Report Initial,Followup
Report Date 06/16/2021
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2021
Initial Date Manufacturer Received 03/15/2021
Initial Date FDA Received03/31/2021
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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