MAUDE Adverse Event Report: COVIDIEN LP ULTRASONIC DISSECTOR

Model Number SCD396

Device Problems Break (1069); Failure to Power Up (1476); Component Missing (2306)

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

Event Type  Injury  

Event Description

The customer originally reported that the device would not activate and that no additional information was available regarding the device and incident.The device was returned for evaluation with a piece of the active waveguide broken.The piece was not returned with the device.The customer was contacted and the site contact stated she was aware that the piece was missing prior to returning it for evaluation.

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.

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 CO 80301
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4110004
• MDR Text Key: 4834349
• Report Number: 1717344-2014-00831
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 254416X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• 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
• Patient Outcome(s): Other