MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SYNERGY* CURVED BLADE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number SNGCB

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It was reported that during a myomectomy, a continuous error sound was heard and the device became not to be activated.The event occurred in two devices.Gen04 was used.Another device was used to complete the case.There were no adverse consequences to the patient.The doctor commented that there was a possibility that the device had contacted with some metallic material or a forceps.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The device was returned with the distal tip of the blade broken off and returned.The remaining blade portion was scratched¿ evidence of contact with metal in or out of the operative field.The device was functionally tested with a generator.During functional testing on gen04 an error code 5 was displayed.A probable cause of the device to stop activating and display an error code 5 is blade damage.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase damage severity and result in an error code 5 or blade lockout later in the procedure, and continued usage can result in a broken blade.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3715007
• MDR Text Key: 18367167
• Report Number: 3005075853-2014-02100
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2014

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: 07/26/2018
• Device Catalogue Number: SNGCB
• Other Device ID Number: BATCH K9209Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR, HANDPIECE