• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number 261221
Device Problem Failure to Auto Stop (2938)
Patient Problem Brain Injury (2219)
Event Date 02/22/2021
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 customer reported that the codman disposable perfortor's safety function failed as the drilling did not stop immediately after the perforation of the skull and damged the patient's dura.No surgical delay was reported.
 
Manufacturer Narrative
The perforator was received 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: the perforator unit was inspected using the unaided eye.Unit was soiled from surgery, and the label was worn to the point it could not be read.Ifu testing was performed with no observed anomalies.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.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.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.
 
Event Description
N/a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA
MDR Report Key11605189
MDR Text Key256753681
Report Number3014334038-2021-00057
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 consumer
Type of Report Initial,Followup
Report Date 06/08/2021
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 Expiration Date05/31/2023
Device Catalogue Number261221
Device Lot NumberHY4365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2021
Initial Date Manufacturer Received 03/09/2021
Initial Date FDA Received04/01/2021
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-