MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. .; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR9F

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/04/2015

Event Type  malfunction  

Event Description

It was reported that during a radical neck dissection procedure, at the beginning of the surgery during the first activation, the tissue pad became loose.Nothing fell into the patient, as the pad was still connected to the device.There was a delay of five minutes.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The device was received with the tissue pad detached but returned with the device.The device was connected to a test handpiece and then functionally tested on the gen11 generator.During functional testing, no yellow alert screens were displayed.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between the blade and tissue pad; and activating the blade without tissue between the blade and tissue pad to avoid damage to the tissue pad.Both conditions can result in probable damage to the instrument.

• Brand Name: .
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; route 22 west po box 151; somerville, NJ 08876 ; 5133378865
• MDR Report Key: 4782664
• MDR Text Key: 21183973
• Report Number: 3005075853-2015-03159
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2015

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: 10/10/2019
• Device Catalogue Number: HAR9F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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: GENERATOR AND HANDPIECE