FDA Adverse Event Malfunction Summary report: N

HARMONIC ACE 36 CM

MDR report key: 1830364 · Received January 14, 2008

Report

Report Number: 1527736-2008-00247
Event Type: Malfunction
Date Received: January 14, 2008
Date of Event: December 13, 2007
Report Date: December 17, 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: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT WHEN ATTEMPTING TO ACTIVATE THE DEVICE ON A GENERATOR GAVE AN ERROR CODE 5. VISUAL EXAMINATION FOUND AN AREA OF THE BLADE THAT WAS DISCOLORED DUE TO HEAT GENERATED FROM CONTACT BETWEEN THE BLADE AND TISSUE PAD. FURTHER ANALYSIS FOUND A CRACK PROPAGATING FROM THE HEAT-AFFECTED AREA OF THE BLADE. 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." EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. COMPLIANT 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 MFG PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAP COLECTOMY PROCEDURE KEPT GETTING SOLID TONE. GOT A NEW DEVICE TO COMPLETE THE PROCEDURE. NO PT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HARMONIC ACE 36 CM		LFL	ETHICON ENDO-SURGERY, INC. (CINCINNATI)	NA	D4JM6H

Patients

Seq	Age	Sex	Outcome	Treatment
1				GENERATOR\| HANDPIECE