UNITED STATES SURGICAL CORPORATION 030449/030426 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-17 for UNITED STATES SURGICAL CORPORATION 030449/030426 * manufactured by United States Surgical Corp..

Event Text Entries

[328287] Staple line at left hepatic vein/vena cava junction was noted to be open after firing endo gia ii 45 2. 0mm during a left hepatectomy, leading to exsanguination. Per surgeon, stapler misfired. Surgeon did not notify team about probelm with stapler until after procedure. No devices were saved and no lot numbers are available. Lot numbers in medical center: endo gia universal #030449 - n4g305, n4f486, n4h243, n4g496, n4h283, n4f154. Endo gia reload 45 2. 0mm #030426 - n4g373, n4d456, n4d462, n4g139, n4e194.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	544534
MDR Report Key	544534
Date Received	2004-09-17
Date of Report	2004-09-16
Date of Event	2004-08-02
Date Facility Aware	2004-08-02
Report Date	2004-09-16
Date Reported to FDA	2004-09-16
Date Reported to Mfgr	2004-09-16
Date Added to Maude	2004-09-21
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	UNITED STATES SURGICAL CORPORATION
Generic Name	STAPLER
Product Code	ESX
Date Received	2004-09-17
Model Number	030449/030426
Catalog Number	*
Lot Number	NOT AVAILABLE
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	UNKNOWN
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	533943
Manufacturer	UNITED STATES SURGICAL CORP.
Manufacturer Address	* NORWALK CT 06856 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-09-17