FDA Adverse Event Malfunction Summary report: N

ULTRACISION HARMONIC ACE

MDR report key: 4780452 · Received May 19, 2015

Report

Report Number: 3005075853-2015-03127
Event Type: Malfunction
Date Received: May 19, 2015
Date of Event: May 11, 2015
Report Date: May 11, 2015
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: LFL
PMA / PMN Number: K042777
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDED ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED AND 100% PRESENT AND NOT DETACHED AS REPORTED BY THE CUSTOMER. THE DEVICE BLADE WAS ALSO NOTED TO BE COMPLETE AND IN GOOD VISUAL CONDITION. THE DEVICE WAS CONNECTED TO A TEST HAND PIECE AND GEN11 AND IT DID ACTIVATE DURING FUNCTIONAL TESTING. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. AVOID ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO PREVENT DAMAGE TO THE TISSUE PAD.

Additional Manufacturer Narrative · 1

(B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC CANCER RADICAL PROCEDURE, THE TITANIUM TIP BROKE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
327115	ULTRACISION HARMONIC ACE	INSTRUMENT, ULTRASONIC SURGICAL	LFL	ETHICON ENDO-SURGERY, LLC.	NA	L90T76

Patients

Seq	Age	Sex	Outcome	Treatment
1				GENERATOR AND HANDPIECE