ENDO GIA* II 45-2.5 DLU

MDR report key: 4157122 · Received October 9, 2014

Report

Report Number: 1219930-2014-00930
Event Type: Injury
Date Received: October 9, 2014
Date of Event: September 15, 2014
Report Date: September 15, 2014
Manufacturer: COVIDIEN, FORMERLY US SURGICAL A DIVISON
Product Code: GAG
PMA / PMN Number: K900129
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

PROCEDURE TYPE: VATS. ACCORDING TO THE REPORTER: THE RELOAD WAS USED IN A VATS SURGERY FOR A MALE PATIENT THEY USED THE RELOAD WITH A NEW EGIA ULTRA STANDARD STAPLER ON THE PULMONARY ARTERY. THE RELOAD DID FIRE THE STAPLE PINS BUT POST RETRACTING THE BLACK KNOB OF THE STAPLER, ITS JAWS DID NOT OPEN. THEY TRIED TO PULL BACK THE KNIFE, BUT WERE NOT SUCCESSFUL. FINALLY THEY HAD TO SUTURE THE ARTERY AND MANAGED TO SAVE THE MIDDLE LOBE OF THE LUNG. PATIENT HAD TO BE SHIFTED TO ICU AND WAS KEPT ON VENTILATOR FOR TWO DAYS UNDER OBSERVATION AS HIS CONDITION WAS CRITICAL. PATIENT IS CURRENTLY STABLE. EGIAUSTND. PRODUCT DESC: EGIA ULTRA UNIVERSAL STAPLER. K083519.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
634787	ENDO GIA* II 45-2.5 DLU	DISPOSABLE SURGICAL STAPLING DEVICE	GAG	COVIDIEN, FORMERLY US SURGICAL A DIVISON	030425	N4B1000LX

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	EGIAUSTND