FDA Adverse Event Malfunction Summary report: N

ULTRACISION SURG DEV, CURVED SHEARS, ENDO

MDR report key: 725783 · Received June 2, 2006

Report

Report Number: 1527736-2006-02520
Event Type: Malfunction
Date Received: June 2, 2006
Date of Event: May 3, 2006
Report Date: May 5, 2006
Manufacturer: ETHICON ENDO-SURGERY, INC.(CINCINNATI)
Product Code: LFL
PMA / PMN Number: K002981
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. THE DEVICE WAS TESTED WITH A GENERATOR AND AN ERROR CODE 5 WAS RECEIVED. THE IDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FROM EXTERNAL CONTACT DURING ACTIVATION. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE" AND "AVOID ACCIDENTAL CONTACT WITH OTHER INSTRUMENTS DURING USE. "THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. 510 (K) IS K002981.

Description of Event or Problem · 1

DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE, THE DEVICE WERE WORKING INTERMITTENLY. TROUBLE SHOOTING WAD DONE AND THE PROBLEM STILL EXISTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ULTRACISION SURG DEV, CURVED SHEARS, ENDO	GEI	LFL	ETHICON ENDO-SURGERY, INC.(CINCINNATI)	NA	C4DC6C

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN			(2) HAND PIECE\| (1) GENERATOR