FDA Adverse Event Malfunction Summary report: N

HARMONIC ACE 36CM W ERG HANDLE

MDR report key: 1830071 · Received September 10, 2010

Report

Report Number: 3005075853-2010-05183
Event Type: Malfunction
Date Received: September 10, 2010
Report Date: August 20, 2010
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: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS SHOWED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. 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

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN COLON PROCEDURE, THE DEVICE CAUSED THE GENERATOR TO ALARM INDICATING THE DEVICE WAS DEFECTIVE. IT WAS THEN NOTICED THAT THE ACTIVE BLADE BROKE OFF OF DEVICE. THE CUSTOMER DID NOT HAVE ANY INFORMATION ON WHETHER THE BROKEN PIECE FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HARMONIC ACE 36CM W ERG HANDLE	INSTRUMENT, ULTRASONIC SURGICAL	LFL	ETHICON ENDO-SURGERY, LLC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				GENERATOR AND HANDPIECE