FDA Adverse Event Injury Summary report: N

ENDO GIA

MDR report key: 18988190 · Received March 27, 2024

Report

Report Number: 3003139373-2024-00060
Event Type: Injury
Date Received: March 27, 2024
Date of Event: February 8, 2024
Report Date: March 27, 2024
Manufacturer: CELESTICA DE MONTERREY S.A. DE C.V.
Product Code: GDW
UDI-DI: 10884523002850
PMA / PMN Number: K111825
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

D10 CONCOMITANT PRODUCT: 030451, 030451 ROTICULTR ENDO GIA 30-2.5 DLU (LOT#T0F163X) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

ACCORDING TO THE REPORTER, DURING A SUB-COSTAL HEPATECTOMY, THERE WAS NO ISSUE WHEN 30 AND 45 MILLIMETER WHITE RELOADS WERE USED. HOWEVER, FIVE HOURS LATER, THE PATIENT WAS TAKEN BACK TO THE EMERGENCY ROOM DUE TO BLEEDING. THE STAPLE LINE OF BOTH RELOADS WERE OPEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
469043	ENDO GIA	STAPLE, IMPLANTABLE	GDW	CELESTICA DE MONTERREY S.A. DE C.V.	030454	T1L061X	10884523002850

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention\| O	SEE H11