FDA Adverse Event Malfunction Summary report: N

ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

MDR report key: 1823691 · Received November 16, 2007

Report

Report Number: 1527736-2007-07824
Event Type: Malfunction
Date Received: November 16, 2007
Report Date: September 26, 2007
Manufacturer: ETHICON ENDO SURGERY, INC. (CINCINNATI)
Product Code: GEI
PMA / PMN Number: K002981
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). BLADE CRACKED-BURNT. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT WHEN ATTEMPTING TO ACTIVATE THE DEVICE ON A GEN04, IT 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. THEREFORE, THE INSTRUCTIONAL 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 DAMAGE TO THE INSTRUMENT." WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, 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 MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE DEVICE DID NOT FUNCTION AFTER FIVE MINUTES. NO FURTHER INFO IS AVAILABLE. THERE WAS NO PT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM		GEI	ETHICON ENDO SURGERY, INC. (CINCINNATI)	NA	D4GJ1M

Patients

Seq	Age	Sex	Outcome	Treatment
1				HANDPIECE\| GENERATOR