FDA Adverse Event Malfunction Summary report: N

HARMONIC ACE 23 CM

MDR report key: 1810047 · Received November 12, 2007

Report

Report Number: 1527736-2007-07529
Event Type: Malfunction
Date Received: November 12, 2007
Date of Event: August 28, 2007
Report Date: August 31, 2007
Manufacturer: ETHICON ENDO SURGERY, INC. (CINCINNATI)
Product Code: LFL
PMA / PMN Number: K042777
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SERIAL NUMBER = NA. EVAL SUMMARY: THE ANALYSIS FOUND THAT THE DEVICE WAS RECEIVED WITH THE BLADE DISCOLORED (BURNT) DUE TO HEAT GENERATED FROM CONTACT BETWEEN THE BLADE AND TISSUE PAD. THE BLADE WAS FOUND TO BE BROKEN AT THE DISCOLORED (BURNT AREA). THIS FAILURE IS CAUSED DUE TO ACTIVATION OF THE DEVICE WHILE CLAMPED WITHOUT TISSUE BEING PRESENT. FOR THIS REASON THE FOLLOWING STATEMENTS WERE INCLUDED IN THE INSTRUCTIONS FOR USE: "CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN DAMAGE TO THE INSTRUMENT." ADDITIONALLY, A BUTTON WAS NOTED TO BE DISLODGED AND INSIDE THE BAG. A POTENTIAL CAUSE OF THIS COULD HAVE BEEN STERILIZATION, DECONTAMINATION AND TRANSFER OF THE INSTRUMENT FROM SHIPPING SITE. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LOBECTOMY THE DEVICE COULD NOT BE USED TO FINISH THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HARMONIC ACE 23 CM		LFL	ETHICON ENDO SURGERY, INC. (CINCINNATI)	NA	D4HA29

Patients

Seq	Age	Sex	Outcome	Treatment
1				HANDPIECE\| GENERATOR