FDA Adverse Event Injury Summary report: N

ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

MDR report key: 8196488 · Received December 26, 2018

Report

Report Number: 3005075853-2018-15416
Event Type: Injury
Date Received: December 26, 2018
Report Date: December 7, 2018
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

Description of Event or Problem · 1

TITLE: INTRACORPOREAL CIRCULAR-STAPLED ESOPHAGOJEJUNOSTOMY USING HAND-SEWN PURSE-STRING SUTURE AFTER LAPAROSCOPIC TOTAL GASTRECTOMY. AUTHOR(S): TAKAHIRO KINOSHITA, TAKASHI OSHIRO, KATSUHIKO ITO, HIDEHITO SHIBASAKI, SHINICHI OKAZUMI, RYOJI KATOH. CITATION: SURG ENDOSC (2010) 24: 2908¿2912; DOI 10.1007/S00464-010-1041-Y. THIS STUDY AIMED TO ASSESS WHETHER A CIRCULAR-STAPLED ANASTOMOSIS USING HAND-SEWN PURSE-STRING SUTURE IS FEASIBLE FOR LAPAROSCOPIC TOTAL GASTRECTOMY (LTG). FROM SEP2008 TO MAY2009, 10 PATIENTS (N=9 MALE AND N=1 FEMALE; MEDIAN AGE OF 63.7 YEARS [RANGE 45-80 YEARS]) WITH GASTRIC CANCER UNDERWENT LTG. IN ALL CASES, "ESOPHAOJEJUNAL" ANASTOMOSIS WAS PERFORMED USING ECS 25-MM CIRCULAR STAPLER. ENDOLOOP WAS APPLY TO REINFORCE THE LIGATION. POSTOPERATIVELY, ONLY ONE PATIENT EXPERIENCED INTRA-ABDOMINAL ABSCESS WHICH WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS. ESOPHAGOJEJUNOSTOMY CAN BE PERFORMED AS IN CONVENTIONAL OPEN SURGERY. HAND-SEWN PURSE-STRING SUTURING IS DEMANDING TECHNICALLY, BUT IT CAN BE PERFORMED SAFELY BY EXPERIENCED LAPAROSCOPIC SURGEONS. THIS TECHNIQUE IS FEASIBLE AND CAN LOWER THE COST OF THE LAPAROSCOPIC PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1035893	ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention