FDA Adverse Event Malfunction Summary report: N

PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

MDR report key: 1250609 · Received November 14, 2008

Report

Report Number: 3005075853-2008-03034
Event Type: Malfunction
Date Received: November 14, 2008
Date of Event: October 20, 2008
Report Date: October 20, 2008
Manufacturer: ETHICON ENDO-SURGERY, LLC
Product Code: GDW
PMA / PMN Number: K020779
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DATE SENT: 11/14/2008. CAM DISENGAGED. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION WITH THE TWO HALVES SEPARATED AND A CARTRIDGE LOADED IN THE DEVICE. THE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL 6 DRIVERS UP WITHOUT STAPLES; THE REMAINING DRIVERS WERE DOWN WITH STAPLES PRESENT. THE FIRING KNOB ADVANCED AND THE CAM WAS DISENGAGED. THE DEVICE CAM WAS REENGAGED MANUALLY AND TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE FIRED. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT		GDW	ETHICON ENDO-SURGERY, LLC	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1