MAUDE Adverse Event Report: COVIDIEN LP ULTRASONIC DISSECTOR

Model Number SCD396

Device Problems Fracture (1260); Loss of Power (1475)

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

Event Date 11/27/2014

Event Type  malfunction  

Event Description

The customer originally reported that during an esophagectomy, a red light was provided by the system and the system stopped working.A new dissector was opened and used to complete the procedure.The device was returned for evaluation fractured and a piece was missing from the active waveguide.The customer was contacted and reported that the piece was not in the patient cavity.

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 not returned with the rest of device.The remaining waveguide was 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 come 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.

• 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: 4413985
• MDR Text Key: 21089783
• Report Number: 1717344-2015-00031
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/27/2014

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: 08/31/2019
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 42380135X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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