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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is alleged that in the course of drilling a burr hole the perforator did not disengage and proceeded to perforate the dura and knick a vessel.The surgeon stopped the bleeding and proceeded with the craniotomy.On (b)(6) 2016 per rep, no further adverse consequences for patient.

Manufacturer Narrative

Upon completion of the investigation it was noted that the customer¿s complaint of "did not disengage " was not verified.This perforator met the test method acceptance requirements; proper engagement and disengagement were achieved with every drill hole.There was no erratic and poor cutting action.The device history records for the perforator was reviewed and all test and inspections associated with the assembly process met specification requirements.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.

• 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 02747
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5402498
• MDR Text Key: 37256750
• Report Number: 1226348-2016-10105
• 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: company representative,foreig
• 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

• 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: KH020S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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