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

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

  • 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
 

CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Catalog Number 26-1221
Device Problem Plunge (1462)
Patient Problem Brain Injury (2219)
Event Date 08/23/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Upon completion of the investigation a follow up report will be filed.
 
Event Description
Failed to stop when it should have and therefore went through the dura.The condition of the patient immediately after the event: "critical".
 
Manufacturer Narrative
The perforator was not returned (discarded) for evaluation; therefore, the root cause of this complaint could not be verified.We will continue to monitor for this or similar complaints for this product code and lot number.The device history records for this perforator were reviewed.All tests and inspections associated with the assembly and manual functional tests met specification requirements.No further action is required.This complaint in considered to be closed at this time.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the customer¿s complaint of "failed to stop" was not verified.This perforator met the test method acceptance requirements; proper engagement and disengagement were achieved with every drill hole.There was no premature disengagement or erratic and poor cutting action.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key5087106
MDR Text Key26150187
Report Number1226348-2015-10530
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number26-1221
Device Lot NumberFH012S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/02/2015
02/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-