FDA Adverse Event Malfunction Summary report: N

HARMONIC ACE 36 CM

MDR report key: 1810039 · Received November 12, 2007

Report

Report Number: 1527736-2007-07534
Event Type: Malfunction
Date Received: November 12, 2007
Date of Event: September 5, 2007
Report Date: September 11, 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). EVALUATION 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". BODY FLUIDS WERE FOUND ON THE BLADE, THIS COULD BE THE REASON OF THE SMOKE. 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 AN UNK PROCEDURE, THE DEVICE COULD NOT BE ACTIVATED AND SMOKE REEKED UP. 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 36 CM		LFL	ETHICON ENDO-SURGERY, INC (CINCINNATI)	NA	D4HL1N

Patients

Seq	Age	Sex	Outcome	Treatment
1				HANDPIECE\| GENERATOR