FDA Adverse Event Malfunction Summary report: N

VASCULAR RELOAD

MDR report key: 6037632 · Received October 18, 2016

Report

Report Number: 3005075853-2016-05950
Event Type: Malfunction
Date Received: October 18, 2016
Date of Event: October 3, 2016
Report Date: October 4, 2016
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K141952
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

Additional Manufacturer Narrative · 1

(B)(4). BATCH # N55316. THE ANALYSIS RESULTS SHOWED THAT ONE VASECR35 RELOAD WAS RECEIVED UNFIRED. THE RETURNED RELOAD WAS LOADED INTO A TEST DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION AND ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC THORACIC SURGERY, A SCRUB NURSE FOUND THAT THE CARTRIDGE WAS DAMAGED WHEN IT WAS OPENED. THE CARTRIDGE WAS CHANGED AND COMPLETED THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
687228	VASCULAR RELOAD	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	N4LR0U

Patients

Seq	Age	Sex	Outcome	Treatment
1