MAUDE Adverse Event Report: CODMAN CODMAN; CODMAN DISPOSABLE PERFORATOR

Catalog Number 16-1221

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2016

Event Type  malfunction  

Event Description

Neurosurgeon was using a burr hold maker when, as it reached the inner cortex, rather than stopping, the device grabbed the inner surface and was forcibly pulled through the inner cortex approx 8 mm through the inner cortex.It stopped at the blue anti-subsidence shield on the codman device.The pulling occurred in spite of the surgeon having his hand rest on the scalp in order to prevent plunging.There was no injury to the pt.

• Brand Name: CODMAN
• Type of Device: CODMAN DISPOSABLE PERFORATOR
• Manufacturer (Section D): CODMAN
• MDR Report Key: 5470672
• MDR Text Key: 39431173
• Report Number: MW5060626
• Device Sequence Number: 1
• Product Code: HBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-1221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 114