EEA 31MM SINGLE-USE STAPLER

MDR report key: 2870124 · Received December 4, 2012

Report

Report Number: 2647580-2012-00757
Event Type: Injury
Date Received: December 4, 2012
Date of Event: November 2, 2012
Report Date: November 8, 2012
Manufacturer: COVIDIEN, FORMERLY USSC PUERTO R
Product Code: GDW
PMA / PMN Number: K062850
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

PROCEDURE TYPE: LAPAROSCOPIC LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: AFTER FIRING, NO ABNORMALITY WAS CONFIRMED BY ENDOSCOPE AND AIR LEAK TEST. TRANSANAL DRAIN WAS PLACED (NO TRANSABDOMINAL DRAIN). SEVERAL HOURS AFTER SURGERY, BLEEDING FROM THE DRAIN WAS CONFIRMED. ARTERIAL HEMORRHAGE FROM THE ANASTOMOSED PART WAS CONFIRMED BY COLONOFIBERSCOPY. IT WAS ASSUMED THE BLEEDING POINT WAS AROUND ONE DOG EAR, SINCE THE OTHER DOG EAR WAS SEEN ON THE OPPOSITE SIDE. ALTHOUGH THE BLEEDING POINT COULD NOT BE IDENTIFIED, THE SURGEON APPLIED CLIPS. THE BLEEDING LESSENED GRADUALLY AND TREATMENT WAS COMPLETED. AMOUNT OF BLEEDING: ABOUT 1,000 CC. BLOOD TRANSFUSION: UNKNOWN. THE PATIENT IS STILL UNDER OBSERVATION, BUT IS MAKING GOOD PROGRESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EEA 31MM SINGLE-USE STAPLER	DISPOSABLE SURGICAL STAPLING DEVICE	GDW	COVIDIEN, FORMERLY USSC PUERTO R

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other