FDA Adverse Event Malfunction Summary report: N

PROXIMATE STAPLER

MDR report key: 3832783 · Received May 27, 2014

Report

Report Number: 3005075853-2014-03553
Event Type: Malfunction
Date Received: May 27, 2014
Date of Event: May 1, 2014
Report Date: May 2, 2014
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: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT 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. 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 THAT DURING A HEMORRHOIDECTOMY, IT WAS FOUND THAT THE ALL STAPLES WERE UNFORMED AFTER FIRING. THE DOCTOR FELT THAT THERE WAS AN UNEXPECTED RESISTANCE WHEN THE DEVICE WAS FIRED. THERE WAS NO UNEXPECTED NOISE. THE TARGET TISSUE WAS CLAMPED PROPERLY. THE HEMORRHOID WAS NOT TOO BIG. THE ADJUSTING KNOB WAS CLOSED PROPERLY PRIOR TO FIRING. HEMORRHOID LIGATION WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310498	PROXIMATE STAPLER	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	K4DC0P

Patients

Seq	Age	Sex	Outcome	Treatment
1