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

Catalog Number 26-1221

Device Problems Plunge (1462); Failure to Auto Stop (2938)

Patient Problem Injury (2348)

Event Date 01/29/2015

Event Type  Injury  

Event Description

Disengagement failure.During surgery, the first perforation with the device in question was done without problem, but during the second perforation, it could not stop and caused a dura injury.Also, the device could not be removed smoothly and disassembled from csr60.The surgeon managed to remove it with a luer.There was no damage on the brain surface.

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 customer¿s complaint of "disengagement failure" was not verified.The customers perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drill hole, and there was no erratic or poor cutting action.No root cause could be determined as no problem was identified.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.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4532261
• MDR Text Key: 5359600
• Report Number: 1226348-2015-10102
• 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: 02/20/2015
• 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: KG016S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• 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