FDA Adverse Event Malfunction Summary report: N

HARMONIC ACE 36 CM

MDR report key: 1823641 · Received November 16, 2007

Report

Report Number: 1527736-2007-07790
Event Type: Malfunction
Date Received: November 16, 2007
Date of Event: October 3, 2007
Report Date: October 5, 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: IN, US
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." COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAP HYSTERECTOMY PROCEDURE THE DEVICE DISPLAYED ERROR CODE 5. THEY COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1				HANDPIECE\| GENERATOR