MAUDE Adverse Event Report: COVIDIEN LP ULTRASONIC DISSECTOR

Model Number SCD391

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

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

Event Date 10/08/2014

Event Type  malfunction  

Event Description

The customer reports that the device left the facility intact.

Manufacturer Narrative

(b)(4).The incident ultrasonic dissector was returned for evaluation.Visual inspection of the disposable hand piece revealed that the device had been used and the static part of the jaw had broken off.The broken piece was returned with the rest of device.The remaining waveguide and the broken piece were inspected under magnification to identify the point of initial contact and fracture.It was concluded that the titanium waveguide fractured during use and eventually broke off.The titanium waveguide may have came in contact with a hard metallic object such as hemostat or retractor as evidenced by the break point and metallic scraping.The user¿s guide for this system warns: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in unintended damage to tissue and/or device failure.

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.

• Brand Name: ULTRASONIC DISSECTOR
• Type of Device: ULTRASONIC DISSECTOR
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4226466
• MDR Text Key: 5045289
• Report Number: 1717344-2014-00964
• 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: 10/13/2014

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: Other
• Device Expiration Date: 08/31/2019
• Device Model Number: SCD391
• Device Catalogue Number: SCD391
• Device Lot Number: 42160115X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/13/2014
• Date Device Manufactured: 08/18/2014
• 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