MAUDE Adverse Event Report: COVIDIEN LP ULTRASONIC DISSECTOR

Model Number SCD391

Device Problems Detachment Of Device Component (1104); Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

The customer originally reported that the device was being used in a low anterior resection for 15 minutes and that the device stopped working and the blade was found to be damaged.Nothing fell into the patient cavity and there was no patient injury.A new dissector was installed onto the system and the procedure was successfully completed.The device was returned for evaluation with a piece of the active waveguide disengaged.The disengaged piece was returned with the device.

Manufacturer Narrative

(b)(4).The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Event Description

New information received states that the device was shipped from (b)(6) intact prior to shipment covidien u.S.The device fractured during transport to covidien u.S.

Manufacturer Narrative

(b)(4).One used sonicision cordless ultrasonic dissector was returned to covidien post market vigilance (pmv) for evaluation.Visual inspection of the disposable device revealed that the dissector had a cracked waveguide.The tip had broken off and was returned with the device.The broken tip was loose in the package and broke off during shipping prior to the device arriving at the covidien post market vigilance lab.The waveguide was inspected under magnification and the origin of the crack was identified.Covidien investigation personnel concluded that the titanium waveguide was in use when it cracked and may have come in contact with any of the following; hemostats, clips, staples, retractors, etc.During use.Device use after damage can cause the cracked waveguide to break off.The device instructions for use currently contain a warning against contact between the dissector tip and metal objects (hemostats, clips, staples, retractors, etc.) during activation.The investigation identified the root cause of the reported event to be user error.

• Brand Name: ULTRASONIC DISSECTOR
• Type of Device: ULTRASONIC DISSECTOR
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4226482
• MDR Text Key: 5077288
• Report Number: 1717344-2014-00965
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

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 Expiration Date: 07/31/2019
• Device Model Number: SCD391
• Device Catalogue Number: SCD391
• Device Lot Number: 41810076X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• Date Device Manufactured: 07/24/2014
• 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
• Treatment: ULTRASONIC REUSABLE GENERATOR - SERIAL # UNKNOWN