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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 Activation, Positioning or Separation Problem (2906)
Patient Problem Brain Injury (2219)
Event Date 04/06/2021
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 physician reported a perforator failed to disengage during cranial surgery for a ruptured aneurysm clipping resulting in a minor dura mater damage.The perforator failed to disengage occurred while making the three burr holes at the tentorium.Hemostasis was performed.No surgical delay was observed.The device was used with eg1(serial;unk).It is unknown if the drill was electric or pneumatic, it is unknown if the perforator clicked into place in the drill, and it is unknown if the recommended spring tests were being performed between each burr hole.The patient is in the follow-up.
 
Manufacturer Narrative
The perforator was not returned for evaluation (as per customer, product not available) therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
Event Description
N/a.
 
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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 Key11749697
MDR Text Key256753823
Report Number3014334038-2021-00085
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,health professional
Type of Report Initial,Followup
Report Date 06/09/2021
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? No
Device Operator Health Professional
Device Catalogue Number261221
Device Lot NumberJ8736H
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/13/2021
Initial Date FDA Received04/29/2021
Supplement Dates Manufacturer Received06/07/2021
Supplement Dates FDA Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age82 YR
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