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

Catalog Number 26-1221

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 06/02/2014

Event Type  Injury  

Event Description

Disengagement failure was noted during surgery conducted for the patient with brain tumor.Perforator could not stop and caused injury to the patient¿s dura.It was reported that the product was not reprocessed.This was occurred with the first perforation in the case.Bleeding was stopped and the case was completed with the site sutured.There were no surgical delay greater than 30 min.

Manufacturer Narrative

Upon completion of investigation, a follow up report will be filed.

Manufacturer Narrative

Supplier evaluation was received on 8/13/2014 and revealed the following: the customers¿ complaint "disengage failure" was not verified.The perforator met functional test method acceptance requirements; proper engagement and disengagement were achieved with every drill hole, there were no premature disengagement, or erratic and poor cutting action.The device history records for this perforator were reviewed.All assembly process tests and inspections associated with assembly process (including 100% functional test to codman (b)(4)), met specification requirements.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC
• Manufacturer (Section D): CODMAN & SHURTLEFF; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3893597
• MDR Text Key: 4542909
• Report Number: 1226348-2014-11747
• 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: 06/25/2014
• 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: BG021S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2014
• 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