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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 Hemorrhage/Bleeding (1888)
Event Date 03/18/2019
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the perforator didn't stop when it arrives to the space between the cranial bone and dura-mater.There was intracranial hemorrhage in patient and a delay in surgery for one hour.The patient outcome was reported as "good".
 
Event Description
N/a.
 
Manufacturer Narrative
Udi (b)(4).The device was returned for evaluation and visually inspected utilizing unaided eye.No anomalies were observed other than a worn label.Test performed and the unit was found to performed as intended.Unit completed testing (5 holes) and was found to performed as intended.Complaint could not be verified as the unit was found to meet all acceptance criteria.A review of quality records was conducted and prior to distribution.This device met all manufacturing and quality testing/inspection specifications.
 
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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 02767
MDR Report Key8460610
MDR Text Key140187757
Report Number1226348-2019-00022
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
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number261221
Device Lot NumberJ03Y99
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Date Manufacturer Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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