FDA Adverse Event Injury Summary report: N

ESOPHYX2 - LINK DESIGN - SHORT

MDR report key: 2914487 · Received January 14, 2013

Report

Report Number: 3005473391-2012-00073
Event Type: Injury
Date Received: January 14, 2013
Date of Event: December 14, 2012
Report Date: December 17, 2012
Manufacturer: ENDOGASTRIC SOLUTIONS, INC
Product Code: ODE
PMA / PMN Number: K092400
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER?BECAUSE THE ADVERSE PATIENT SYMPTOMS PRESENTED ITSELF SOMETIME AFTER THE PROCEDURE, THE DEVICE HAD ALREADY BEEN DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR EVALUATION.NO ALLEGATION OF PRODUCT MALFUNCTION.

Description of Event or Problem · 1

AFTER A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE PATIENT DID WELL THROUGH THE NIGHT. IN THE MORNING, BECAUSE OF BLOOD IN THE STOOL, THE PHYSICIAN PERFORMED AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND BLOOD WAS FOUND IN THE FUNDUS OF THE STOMACH. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND A 6CM LACERATION IN THE FUNDUS WAS FOUND. A THORACIC SURGEON AT THAT HOSPITAL PERFORMED A RIGHT THORACOTOMY AND APPLIED A LINEAR STAPLE LINE TO THE LACERATION OF THE FUNDUS. THE PATIENT WAS DISCHARGED, IS DOING WELL WITH NO OTHER COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20177	ESOPHYX2 - LINK DESIGN - SHORT	ODE	ODE	ENDOGASTRIC SOLUTIONS, INC	R2002

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R