FDA Adverse Event Other Summary report: N

LINA GOLD LOOP

MDR report key: 3177568 · Received June 7, 2013

Report

Report Number: 3007699067-2013-00003
Event Type: Other
Date Received: June 7, 2013
Date of Event: April 8, 2013
Report Date: April 8, 2013
Manufacturer: LINA MEDICAL POLSKA
Product Code: KNF
PMA / PMN Number: D017698
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INCOMPLETE PRODUCT HAS BEEN RETURNED, SO THERE WAS NOT POSSIBLE TO PERFORM FULL INVESTIGATION. RETURNED PART WAS THE FIBRE TUBE WITH THE ADAPTER. A1 THE WIRES, PLUG, HANDLE, TUBE AND FUNNEL HAS NOT BEEN RETURNED. ASSUMING FORM COMPLAINT DESCRIPTION, THE FUNNEL DETACHED FROM THE FIBRE TUBE. THE TUBE WAS EXAMINED AND RESIDUES OF GLUE ON THE TUBE WAS FOUND. HOWEVER WITHOUT THE FUNNEL IT IS NOT POSSIBLE TO DETERMINE DIRECT ROOT CAUSE. IT IS POSSIBLE THAT THERE WAS TO LESS GLUE USED DURING ASSEMBLING PROCESS OR THERE WAS ADDITIONAL STRENGTH PUT ON A FUNNEL DURING SURGERY WHICH CAUSED THE FUNNEL TO FALL DOWN. HOWEVER THERE ARE ONLY ASSUMPTIONS AND THE REAL ROOT CAUSE CAN NOT BE DETERMINED.

Description of Event or Problem · 1

SURGEON PLACED THROUGH PORT AND WENT OPEN. "LOOP" BROKE OFF IN PT. HAD TO REMOVE AND RETRIEVE BROKEN PIECE BEFORE PROCEEDING WITH CASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
253882	LINA GOLD LOOP	LOOP	KNF	LINA MEDICAL POLSKA	EL-200-8	12211

Patients

Seq	Age	Sex	Outcome	Treatment
1