FDA Adverse Event Malfunction Summary report: N

PROXIMATE PPH PROCEDURE SET

MDR report key: 3122400 · Received May 21, 2013

Report

Report Number: 3005075853-2013-02460
Event Type: Malfunction
Date Received: May 21, 2013
Date of Event: January 11, 2013
Report Date: April 29, 2013
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K051301
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). BREAKAWAY WASHER CUT OFF CENTER. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE KNIFE DAMAGED; THE BREAKAWAY WASHER WAS PRESENT AND WITH AN OFF-CENTER CUT. IT APPEARS POSSIBLE THAT THE ANVIL WAS PUSHED FAR ENOUGH OFF CENTER TO RESULT IN AN OFF CENTER CUT OF THE BREAKAWAY WASHER AND DAMAGE THE KNIFE BY PRESSING IT HARD ENOUGH AGAINST THE ANVIL. THIS SITUATION NORMALLY OCCURS WHEN THE TISSUE IS NOT EVENLY DISTRIBUTED IN THE DEVICE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY, IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT, HOWEVER THE WASHER CUT WAS NOT A PERFECT CIRCLE DUE TO THE DAMAGED KNIFE. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED BY THE CUSTOMER THAT DURING A PPH PROCEDURE, WHEN THE STAPLER WAS FIRED THE WHITE RING DID NOT BREAK COMPLETELY TO ALLOW STAPLES TO FORM A COMPLETE STAPLE LINE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
224517	PROXIMATE PPH PROCEDURE SET	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	UNK	J4CD55

Patients

Seq	Age	Sex	Outcome	Treatment
1