MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISP PERFORATOR 11MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1222

Device Problem Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Date 01/29/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The craniectomy was performed to remove a tumor and patient was fully conscious during the procedure.The trepan did not stop after perforation of the bone and therefor heavily damaged the subjacent dura.The injury of the dura was closed.It is not clear at the moment whether there will any further subsequent damages for the patient.

Manufacturer Narrative

Device evaluation: upon completion of the investigation it was noted that the customer¿s complaint of "trepan did not stop after perforation of the bone and therefore heavily damaged the subjacent dura" was not verified.This perforator met the test method acceptance requirements; proper engagement and disengagement were achieved with every drill hole and 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 DISP PERFORATOR 11MM
• 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 Key: 5448047
• MDR Text Key: 38631162
• Report Number: 1226348-2016-10130
• 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

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1222
• Device Lot Number: KH0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• 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