HARMONIC ACE 36 CM

Report

Report Number: 3005075853-2008-02176
Event Type: Malfunction
Date Received: October 7, 2008
Date of Event: July 8, 2008
Report Date: July 25, 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: MX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED AND WITH B-FORMED STAPLES EMBEDDED INTO THE TISSUE PAD. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED AND THE BLADE TIP FURTHER CRACKED. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 AND A SOLID TONE OF THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. A POSSIBLE CAUSE OF AN ERROR CODE 5 (INSTRUMENT ERROR) IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THE MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. 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 GASTRIC BYPASS PROCEDURE, THE DEVICE STOPPED WORKING AND THE GENERATOR STARTED TO SHOW THE MESSAGE NUMBER 5 (REPLACE INSTRUMENT). ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1				STAPLER\| HANDPIECE\| GENERATOR