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

Catalog Number 26-1221

Device Problem Fail-Safe Problem (2936)

Patient Problem Contusion (1787)

Event Date 12/17/2014

Event Type  Injury  

Event Description

Event: the perforator did not disengage ,leading to a brain contusion.No other consequence reported.Ansm ref (b)(4), event reported by customer.Did this event occur intra-operatively? yes.Was there a delay in surgery over 30 minutes? no information.Where there any adverse consequences to the patient? brain contusion.What actions were taken as a result of this incident? no further details.Is the device being returned for evaluation? no information.

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the perforator was not returned for evaluation; therefore, the root cause of this complaint could not be verified.The device history records for the perforator was reviewed and all test and inspections associated with the assembly process met specification requirements prior to distribution.This complaint in considered to be closed at this time.Should the perforator be returned at a later date this complaint will be reopened and an investigation will be performed.Trends will be monitored for this and similar complaints.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4398853
• MDR Text Key: 18024843
• Report Number: 1226348-2015-10014
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: KGO15S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention