FDA Adverse Event Malfunction Summary report: N

HARMONIC ACE 36 CM

MDR report key: 1080513 · Received July 24, 2008

Report

Report Number: 3005075853-2008-00444
Event Type: Malfunction
Date Received: July 24, 2008
Date of Event: June 18, 2008
Report Date: June 18, 2008
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: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DATE SENT: 07/12/2008. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD PARTIALLY DETACHED. BASED ON THE CONDITION OF THE TISSUE PAD, IT APPEARS POSSIBLE THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. THIS DAMAGE OCCURS WHEN THE INSTRUMENT IS ACTIVATED WITHOUT TISSUE PRESENT. OUR INSTRUCTION INSERT STATES: "CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT." BOTH CONDITIONS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED AND KEEP THE CLAMP ARM OPEN WHEN BACKCUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. COMPLAINT INFO 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 MFG PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN LSH PROCEDURE, THE TISSUE PAD WAS LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HARMONIC ACE 36 CM	NONE	LFL	ETHICON ENDO-SURGERY, LLC	NA	E4L53P

Patients

Seq	Age	Sex	Outcome	Treatment
1				HANDPIECE\| GENERATOR