EEA 28MM SINGLE-USE STAPLER

MDR report key: 4808650 · Received June 1, 2015

Report

Report Number: 2647580-2015-00397
Event Type: Injury
Date Received: June 1, 2015
Date of Event: May 5, 2015
Report Date: May 19, 2015
Manufacturer: COVIDIEN, FORMERLY USSC PUERTO RICO INC
Product Code: GDW
PMA / PMN Number: K062850
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

THE SURGEON REPORTED HE IS NOT 100% THE DEVICE USED IN THE SURGERY WAS AN EEA28 AS THERE WERE NO ISSUES IN THE SURGERY AND THE DEVICE WAS DISCARDED. CORRECTION 510K NUMBER FOR EEA28: K062850.

Description of Event or Problem · 1

PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: A COLECTOMY WAS PERFORMED ON (B)(6) 2015 AND THERE WAS NO ISSUE DURING THE SURGERY. IN THE POSTOPERATIVE PERIOD THE PATIENT PRESENTED WITH BLEEDING AND A COLONOSCOPY CONFIRMED BLEEDING IN THE ANASTOMOSIS. THE BLOOD LOSS WAS MORE THAN 500CC AND THE PATIENT REQUIRED TRANSFUSION. THERE WAS NO UNANTICIPATED TISSUE LOSS OR TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE SURGEON STATED THE ISSUE MAY HAVE BEEN RELATED TO INCORRECT STAPLE SIZE SELECTION. LAST KNOWN PATIENT STATUS: THE PATIENT WAS RECOVERING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352759	EEA 28MM SINGLE-USE STAPLER	DISPOSABLE SURGICAL STAPLING DEVICE	GDW	COVIDIEN, FORMERLY USSC PUERTO RICO INC	EEA28	NOT AVAILABLE

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R