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 No Code Available (3191)

Event Date 03/18/2014

Event Type  Injury  

Event Description

Customer called and reported that: "a codman disposable perforator plunged twice into the patient's brain.It failed to disengage both times.However, patient is okay and surgery was not delayed for more than 30 minutes.Please send a warranty replacement to the customer".

Manufacturer Narrative

Upon completion of the investigation, it was noted that the perforator was evaluated by the supplier and it was found to be within specifications.This perforator met all functional testing requirements.The root cause of the reported problem was not determined.All evaluation tests and inspections had acceptable results.The perforator met functional test method acceptance requirements; proper engagement was achieved with every drilled hole, and there was no premature disengagement.A review of the device history records did not reveal any anomalies.We will continue to monitor for this or similar complaints for this product code.At the present time, this complaint is considered 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 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3748581
• MDR Text Key: 4482133
• Report Number: 1226348-2014-11360
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• 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: JF019S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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
• Patient Age: 61 YR