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

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD 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
 

INTEGRA LIFESCIENCES MANSFIELD 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 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 facility reported a perforator failed to stop and plunged into patient's dura and brain, causing a small contusion found on a post-op ct.The event led to 20 minutes surgical delay.
 
Manufacturer Narrative
The perforator was returned for evaluation: dhr: there is no indication that the production process may have contributed to this complaint.Failure analysis: the perforator unit was inspected using the unaided eye.The unit was observed to have a destroyed label.The unit was also noticed to have been autoclaved, therefore the blue sleeve was deformed.Ifu testing was performed after freeing the hudson end, likely fused due to being autoclaved.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.Even though the complaint could not be verified through failure analysis, potential root cause was investigated, potential root cause includes perforator components cannot withstand multiple sterilizations/uses, impact introduction of drill to skull able to cause scoring on the pin/triangle/slot interface, inadequate spring (k-factor and/or length), drill used for multiple holes; chatter/deformation of pin/slot interface, drill allows to be set incorrectly, incorrect specification of surface finish for inner drill outer drill and pin, or user misuse.
 
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)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
MDR Report Key11528802
MDR Text Key243469328
Report Number3014334038-2021-00049
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 06/02/2021
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 NumberJ82P47
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2021
Initial Date Manufacturer Received 03/02/2021
Initial Date FDA Received03/19/2021
Supplement Dates Manufacturer Received05/24/2021
Supplement Dates FDA Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-