MAUDE Adverse Event Report: COVIDIEN; CAUTERY DEVICE IN SPINAL FUSION PACK

Catalog Number CDS983350L

Device Problems Component Falling (1105); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that during a spine procedure, a piece separated from the cautery tip and fell into the incision site.The plastic piece was manually removed using forceps without further incident.No serious injury resulted.No additional intervention was indicated.The sample was received.Upon visual inspection it was noted that the blade of the component was charred, the blue insulation layer was stretched and the plastic piece was separated from the cautery tip.Two unused samples were tested in both the cut and coag modes and functioned as intended.This device is a component in a custom surgical pack and is manufactured by (b)(4).As the manufacturer of the device, (b)(4) will conduct an investigation and make the determination if any corrective action is indicated.

Event Description

It was reported that the plastic piece separated from the cautery tip and fell into the incision site.

• Type of Device: CAUTERY DEVICE IN SPINAL FUSION PACK
• Manufacturer (Section D): COVIDIEN; 150 glover avenue; norwalk CT 06856
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5406842
• MDR Text Key: 37383200
• Report Number: 1423395-2016-00007
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS983350L
• Device Lot Number: 15IB0152
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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): Other
• Patient Age: 13 YR