GIA80-3.8 SINGLE USE RELOADABLE STAPLER

MDR report key: 3964236 · Received July 14, 2014

Report

Report Number: 2647580-2014-00534
Event Type: Injury
Date Received: July 14, 2014
Date of Event: April 8, 2014
Report Date: May 11, 2018
Manufacturer: COVIDIEN, FORMERLY USSC PUERTO RICO
Product Code: GDW
PMA / PMN Number: K013860
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY : POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE.NO VISUAL OR FUNCTIONAL ABNORMALITIES WERE NOTED DURING EVALUATION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

PROCEDURE: VATS, ACCORDING TO THE REPORTER: THE LOAD DID NOT CLOSE THE LUNG. IT WAS NECESSARY TO CONVERT THE VIDEOLAPAROSCOPIC PROCEDURE TO AN OPEN ONE. NO INJURY REPORTED. NO PERMANENT DAMAGE. THERE WAS NO BLEEDING OVER THAN 500 CC. IT WAS NOT NECESSARY BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED. THE EVENT PROLONGED THE HOSPITAL STAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
410186	GIA80-3.8 SINGLE USE RELOADABLE STAPLER	DISPOSABLE SURGICAL STAPLING DEVICE	GDW	COVIDIEN, FORMERLY USSC PUERTO RICO		P3G0420X

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other