FDA Adverse Event Malfunction Summary report: N

ECHELON LINEAR CUTTER RELOAD

MDR report key: 3943833 · Received July 18, 2014

Report

Report Number: 3005075853-2014-05076
Event Type: Malfunction
Date Received: July 18, 2014
Date of Event: July 7, 2014
Report Date: July 7, 2014
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K051002
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT WAS THE PRODUCT CODE AND LOT/BATCH NUMBER FOR THE STAPLER USED WITH THE ECR45G CARTRIDGE (EX, EC45, SC45, EC45A, ETC)? PLEASE SEND PICTURES VIA EMAIL TO (B)(4). WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE THIS EVENT? WHAT WAS THE PATIENT¿S BMI? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT?

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, DURING THE SECOND FIRING, THE RELOAD WAS USED. WHEN THE JAW WAS OPENED ALL THREE ROWS ON THE SPECIMEN SIDE WERE FULLY FORMED, HOWEVER, ON THE PATIENT SIDE ONE ROW WAS FORMED. THE OTHER TWO ROWS WERE DEPLOYED IN THE "U" SHAPE FORMATION AND NOT FORMED. THE SURGEON USED CLIPS TO REINFORCE THE STAPLE LINE PRIOR TO INITIATING THE NEXT FIRING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL NOT BE RELEASED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
422067	ECHELON LINEAR CUTTER RELOAD	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1